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Alternatives for Reducing Chorea in Huntington Disease (ARC-HD)

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ClinicalTrials.gov Identifier: NCT01897896
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chorea Associated With Huntington Disease
Intervention Drug: SD-809
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description Participants who completed study SD-809-C-15 (either placebo or SD-809 group [NCT01795859], including 1-week washout period and Week 13 evaluation), received 6 milligrams(mg) SD-809 ER tablet once daily as starting dose in this study. Dose titration was continued through Week 8 to optimize dose. SD-809 ER dose could be adjusted weekly in increments of 6 milligrams per day(mg/day) (6 or 12 mg/day after total daily dose of 48 mg reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day(36 mg twice daily), unless participant was receiving a strong CYP2D6 inhibitor(e.g., paroxetine,buproprion, fluoxetine), in which case maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. Participants who were receiving Food and Drug Administration (FDA) - approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state area under the curve(AUC) of total (alpha+beta)-Dihydrotetrabenazine(HTBZ) metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. SD-809 ER dose could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after total daily dose of 48 mg reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Period Title: Overall Study
Started 82 37
Completed 56 25
Not Completed 26 12
Reason Not Completed
Death             1             0
Adverse Event             11             1
Lost to Follow-up             1             0
Non-compliance with study drug dosing             1             1
Withdrawal by Subject             7             1
Require drug that interfere with study             1             4
Protocol Violation             1             1
Withdrawal per Investigator’s judgement             1             1
Caregiver can no longer participate             0             2
Other than specified             2             1
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER Total
Hide Arm/Group Description Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. Total of all reporting groups
Overall Number of Baseline Participants 82 37 119
Hide Baseline Analysis Population Description
Safety population included all participants who were administered at least 1 dose of drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 37 participants 119 participants
53.7  (12.27) 52.4  (11.48) 53.3  (12.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 37 participants 119 participants
Female
37
  45.1%
15
  40.5%
52
  43.7%
Male
45
  54.9%
22
  59.5%
67
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 37 participants 119 participants
Hispanic or Latino
0
   0.0%
2
   5.4%
2
   1.7%
Not Hispanic or Latino
82
 100.0%
35
  94.6%
117
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 37 participants 119 participants
Black or African American
4
   4.9%
0
   0.0%
4
   3.4%
White
76
  92.7%
36
  97.3%
112
  94.1%
Other
0
   0.0%
1
   2.7%
1
   0.8%
Multiple
2
   2.4%
0
   0.0%
2
   1.7%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline to follow-up visit (up to approximately 3 years 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
77
  93.9%
35
  94.6%
Serious TEAEs
21
  25.6%
11
  29.7%
Severe TEAEs
17
  20.7%
7
  18.9%
Drug-Related TEAEs
56
  68.3%
26
  70.3%
TEAEs Leading to Withdrawal From Study
13
  15.9%
3
   8.1%
2.Primary Outcome
Title Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Day 1 to end of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug.
Arm/Group Title Rollover Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
49
  59.8%
Serious TEAEs
1
   1.2%
Severe TEAEs
0
   0.0%
Drug-Related TEAEs
23
  28.0%
TEAEs Leading to Withdrawal From Study
0
   0.0%
3.Primary Outcome
Title Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Day 1 to end of Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants received at least 1 dose of study drug.
Arm/Group Title Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
17
  45.9%
Serious TEAEs
1
   2.7%
Severe TEAEs
1
   2.7%
Drug-Related TEAEs
11
  29.7%
TEAEs Leading to Withdrawal From Study
0
   0.0%
4.Primary Outcome
Title Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Week 8 to follow-up visit (up to approximately 3 years 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 81 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
74
  91.4%
35
 100.0%
Serious TEAEs
20
  24.7%
10
  28.6%
Severe TEAEs
17
  21.0%
7
  20.0%
Drug-Related TEAEs
49
  60.5%
22
  62.9%
TEAEs Leading to Withdrawal From Study
13
  16.0%
3
   8.6%
5.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158
Hide Description Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets cells at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed values at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophils: Baseline Number Analyzed 82 participants 37 participants
0.029  (0.0231) 0.035  (0.0283)
Basophils: Change at Week 158 Number Analyzed 18 participants 8 participants
-0.014  (0.0287) -0.004  (0.0385)
Eosinophils: Baseline Number Analyzed 82 participants 37 participants
0.151  (0.1274) 0.195  (0.1366)
Eosinophils: Change at Week 158 Number Analyzed 18 participants 8 participants
-0.054  (0.0784) 0.009  (0.0911)
Leukocytes: Baseline Number Analyzed 82 participants 37 participants
6.98  (2.083) 6.97  (1.828)
Leukocytes: Change at Week 158 Number Analyzed 18 participants 8 participants
-0.04  (0.927) -0.04  (1.098)
Lymphocytes: Baseline Number Analyzed 82 participants 37 participants
1.922  (0.7674) 1.789  (0.7088)
Lymphocytes: Change at Week 158 Number Analyzed 18 participants 8 participants
-0.088  (0.4261) 0.075  (0.5409)
Monocytes: Baseline Number Analyzed 82 participants 37 participants
0.445  (0.1805) 0.416  (0.1416)
Monocytes: Change at Week 158 Number Analyzed 18 participants 8 participants
-0.129  (0.1722) -0.068  (0.1335)
Neutrophils: Baseline Number Analyzed 82 participants 37 participants
4.437  (1.6324) 4.538  (1.4741)
Neutrophils: Change at Week 158 Number Analyzed 18 participants 8 participants
0.243  (0.6359) -0.050  (0.8166)
Platelets: Baseline Number Analyzed 82 participants 37 participants
235.6  (62.81) 247.2  (77.63)
Platelets: Change at Week 158 Number Analyzed 18 participants 8 participants
1.2  (56.09) -12.0  (26.59)
6.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158
Hide Description Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes mean corpuscular volume at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: femtoliter (fL)
Baseline Number Analyzed 82 participants 37 participants
91.1  (3.95) 92.1  (5.39)
Change at Week 158 Number Analyzed 18 participants 8 participants
2.2  (3.23) 1.6  (4.14)
7.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158
Hide Description Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Baseline Number Analyzed 82 participants 37 participants
4.60  (0.397) 4.54  (0.377)
Change at Week 158 Number Analyzed 18 participants 8 participants
0.18  (0.262) 0.19  (0.247)
8.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158
Hide Description Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Hematocrit levels were calculated as the ratio of the volume of red cells to the volume of whole blood. Change from baseline in hematocrit at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline Number Analyzed 82 participants 37 participants
0.419  (0.0363) 0.417  (0.0397)
Change at Week 158 Number Analyzed 18 participants 8 participants
0.025  (0.0255) 0.025  (0.0334)
9.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158
Hide Description Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in hemoglobin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: grams per liter (g/L)
Baseline Number Analyzed 82 participants 37 participants
139.7  (12.26) 138.4  (13.19)
Change at Week 158 Number Analyzed 18 participants 8 participants
4.6  (7.99) 4.5  (11.99)
10.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in alanine aminotransferase and alkaline phosphatase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: international units per liter (IU/L)
Alanine Aminotransferase: Baseline Number Analyzed 82 participants 37 participants
20.7  (9.74) 18.9  (12.20)
Alanine Aminotransferase: Change at Week 158 Number Analyzed 19 participants 9 participants
-5.3  (7.51) -2.1  (9.74)
Alkaline Phosphatase: Baseline Number Analyzed 82 participants 37 participants
72.6  (20.24) 73.1  (20.61)
Alkaline Phosphatase: Change at Week 158 Number Analyzed 19 participants 9 participants
-1.0  (8.21) 1.0  (9.62)
11.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in aspartate aminotransferase and lactate dehydrogenase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
Aspartate Aminotransferase: Baseline Number Analyzed 82 participants 37 participants
20.5  (5.84) 18.4  (6.88)
Aspartate Aminotransferase: Change at Week 158 Number Analyzed 19 participants 9 participants
-2.7  (5.43) -1.1  (5.40)
Lactate Dehydrogenase: Baseline Number Analyzed 81 participants 37 participants
163.9  (28.05) 161.1  (42.32)
Lactate Dehydrogenase: Change at Week 158 Number Analyzed 19 participants 9 participants
-5.5  (27.83) -4.9  (18.45)
12.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium and triglycerides at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Bicarbonate: Baseline Number Analyzed 82 participants 37 participants
24.7  (2.55) 24.7  (2.06)
Bicarbonate: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.2  (2.87) 0.7  (3.16)
Blood Urea Nitrogen: Baseline Number Analyzed 82 participants 37 participants
5.979  (1.8432) 6.282  (1.8177)
Blood Urea Nitrogen: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.531  (1.4864) -0.323  (0.9797)
Calcium: Baseline Number Analyzed 82 participants 37 participants
2.417  (0.1067) 2.393  (0.1523)
Calcium: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.034  (0.1282) -0.067  (0.0869)
Chloride: Baseline Number Analyzed 82 participants 37 participants
102.5  (2.28) 103.8  (2.24)
Chloride: Change at Week 158 Number Analyzed 19 participants 9 participants
-2.7  (2.62) -2.0  (1.50)
Cholesterol: Baseline Number Analyzed 82 participants 37 participants
5.118  (0.9505) 4.863  (1.1686)
Cholesterol: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.131  (0.8790) -0.173  (0.7715)
Glucose: Baseline Number Analyzed 82 participants 37 participants
5.28  (1.571) 5.31  (1.029)
Glucose: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.54  (1.018) -0.64  (1.033)
Magnesium: Baseline Number Analyzed 82 participants 37 participants
0.871  (0.0566) 0.843  (0.0567)
Magnesium: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.027  (0.0701) 0.016  (0.0639)
Phosphate: Baseline Number Analyzed 82 participants 37 participants
1.194  (0.1769) 1.191  (0.1661)
Phosphate: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.029  (0.2298) 0.061  (0.1330)
Potassium: Baseline Number Analyzed 82 participants 37 participants
4.39  (0.419) 4.46  (0.332)
Potassium: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.14  (0.414) 0.19  (0.501)
Sodium: Baseline Number Analyzed 82 participants 37 participants
142.4  (2.14) 142.9  (2.31)
Sodium: Change at Week 158 Number Analyzed 19 participants 9 participants
-2.0  (3.56) -1.7  (2.06)
Triglycerides: Baseline Number Analyzed 82 participants 37 participants
1.606  (1.0001) 1.733  (1.2887)
Triglycerides: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.147  (0.8692) -0.420  (1.0005)
13.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in protein and albumin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: g/L
Protein: Baseline Number Analyzed 82 participants 37 participants
69.5  (3.88) 67.3  (4.54)
Protein: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.9  (3.54) -2.9  (4.43)
Albumin: Baseline Number Analyzed 82 participants 37 participants
43.9  (2.55) 43.1  (2.65)
Albumin: Change at Week 158 Number Analyzed 19 participants 9 participants
0.2  (3.61) -0.9  (2.57)
14.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in creatinine clearance at baseline and Week 106 is reported in this outcome measure. Observed value at baseline and observed value at Week 106 were used to calculate the change from baseline value at Week 106.
Time Frame Baseline, Week 106
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: milliliters per minute (mL/min)
Baseline Number Analyzed 81 participants 36 participants
94.1  (26.67) 89.9  (27.55)
Change at Week 106 Number Analyzed 2 participants 1 participants
-4.5  (6.36) -34.0
15.Secondary Outcome
Title Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158
Hide Description Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bilirubin, creatinine, direct bilirubin, and urate at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.
Time Frame Baseline, Week 158
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Bilirubin: Baseline Number Analyzed 82 participants 37 participants
7.8  (4.82) 6.0  (2.43)
Bilirubin: Change at Week 158 Number Analyzed 19 participants 9 participants
-0.7  (2.51) -1.4  (2.07)
Creatinine: Baseline Number Analyzed 82 participants 37 participants
82.8  (16.81) 84.2  (19.02)
Creatinine: Change at Week 158 Number Analyzed 19 participants 9 participants
-2.4  (10.13) -2.4  (6.46)
Direct Bilirubin: Baseline Number Analyzed 81 participants 37 participants
2.4  (0.94) 2.1  (0.35)
Direct Bilirubin: Change at Week 158 Number Analyzed 19 participants 9 participants
0.1  (0.23) -0.2  (0.44)
Urate: Baseline Number Analyzed 82 participants 37 participants
305.2  (83.70) 269.5  (75.06)
Urate: Change at Week 158 Number Analyzed 19 participants 9 participants
-21.8  (55.50) -3.4  (39.37)
16.Secondary Outcome
Title Change From Baseline in Blood Pressure at Week 171
Hide Description Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
SBP: Baseline Number Analyzed 78 participants 37 participants
120.5  (12.70) 118.9  (17.80)
SBP: Change at Week 171 Number Analyzed 1 participants 0 participants
-4.0
DBP: Baseline Number Analyzed 78 participants 37 participants
73.3  (10.21) 73.8  (11.85)
DBP: Change at Week 171 Number Analyzed 1 participants 0 participants
-6.0
17.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 171
Hide Description Heart rate was assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline Number Analyzed 78 participants 37 participants
70.7  (8.68) 68.1  (12.56)
Change at Week 171 Number Analyzed 1 participants 0 participants
25.0
18.Secondary Outcome
Title Change From Baseline in Respiration Rate at Week 171
Hide Description Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: breaths/minute
Baseline Number Analyzed 78 participants 37 participants
16.4  (2.57) 17.5  (2.58)
Change at Week 171 Number Analyzed 7 participants 2 participants
-1.3  (2.06) -3.5  (3.54)
19.Secondary Outcome
Title Change From Baseline in Body Temperature at Week 171
Hide Description Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: degrees centigrade
Baseline Number Analyzed 79 participants 37 participants
36.56  (0.427) 36.67  (0.309)
Change at Week 171 Number Analyzed 7 participants 2 participants
-0.13  (0.468) -0.10  (0.283)
20.Secondary Outcome
Title Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8
Hide Description ECG parameters included heart rate, PR interval, QRS duration, QT interval and Fridericia’s corrected QT interval (QTcF). Heart rate measured by ECG at Baseline and Week 8 is reported in this outcome measure.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: beats/minute
Baseline Number Analyzed 82 participants 37 participants
67.4  (9.87) 63.8  (13.96)
Week 8 Number Analyzed 78 participants 35 participants
64.6  (9.22) 65.8  (13.50)
21.Secondary Outcome
Title ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8
Hide Description ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. PR interval, QRS duration, QT interval and QTcF at Baseline and Week 8 is reported in this outcome measure.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: milliseconds
PR Interval: Baseline Number Analyzed 81 participants 37 participants
164.1  (25.03) 159.5  (22.65)
PR Interval: Week 8 Number Analyzed 78 participants 35 participants
165.2  (23.87) 155.7  (18.08)
QRS Duration: Baseline Number Analyzed 82 participants 37 participants
92.8  (14.37) 88.8  (10.16)
QRS Duration: Week 8 Number Analyzed 78 participants 35 participants
91.0  (12.09) 88.0  (10.97)
QT Interval: Baseline Number Analyzed 82 participants 37 participants
399.8  (27.44) 415.6  (37.44)
QT Interval: Week 8 Number Analyzed 78 participants 35 participants
405.1  (29.10) 404.5  (35.43)
QTcF: Baseline Number Analyzed 82 participants 37 participants
413.3  (18.67) 419.3  (17.89)
QTcF: Week 8 Number Analyzed 78 participants 35 participants
412.7  (20.10) 412.8  (18.05)
22.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in ECG Parameters
Hide Description ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. Clinical significance was as as per Investigator's discretion.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 82 participants 37 participants
5
   6.1%
0
   0.0%
Week 8 Number Analyzed 78 participants 35 participants
2
   2.6%
0
   0.0%
23.Secondary Outcome
Title Duration of Time to Achieve a Stable Dose of SD-809 ER
Hide Description Duration of time to achieve stable dose of SD-809, defined as the number of days from Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8.
Time Frame From Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8 (up to maximum 1284 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 81 35
Median (Full Range)
Unit of Measure: days
47.0
(1 to 73)
28.0
(1 to 76)
24.Secondary Outcome
Title Change From Baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171
Hide Description The UPDRS is a comprehensive instrument used to assess the signs and symptoms of Parkinson’s disease and includes patient and clinician-based assessments of motor, cognitive, and behavioral symptoms. The UPDRS-Dysarthria question pertaining to speech/dysarthria was used to monitor study participants for parkinsonism. Participants rated their responses on a scale ranging from 0 to 4, where 0 = normal; 1 = mildly affected, no difficulty being understood; 2 = moderately affected, sometimes asked to repeat statements; 3 = severely affected, frequently asked to repeat statements; 4 = unintelligible most of the time. Higher scores indicated greater impairment.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
0.9  (0.79) 1.1  (0.74)
Change at Week 171 Number Analyzed 7 participants 2 participants
0.4  (0.79) 1.5  (0.71)
25.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171
Hide Description BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures [self-awareness and distress]) and a global clinical assessment. Objective akathisia rated on a scale of 0-3 (0=normal, occasional fidgety movements of limbs; 1=characteristic restless movements for less than half the time observed; 2= characteristic restless movements for at least half the time observed; 3=constant characteristic restless movements). Subjective measures included awareness of restlessness (rated on a scale of 0 [absence of inner restlessness] to 3 [awareness of intense compulsion to move]) and distress related to restlessness (rated on a scale of 0 [no distress] to 3 [severe distress]). Objective akathisia and subjective measures summed to yield summary score ranging from 0 (no akathisia and restlessness) to 9 (severe akathisia and restlessness), where higher scores indicated more akathisia and restlessness.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
1.1  (1.67) 0.8  (1.25)
Change at Week 171 Number Analyzed 7 participants 2 participants
0.7  (1.50) 0.5  (3.54)
26.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171
Hide Description BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures [self-awareness and distress]) and a global clinical assessment. Global clinical assessment rated on a scale ranging from 0 to 5, where 0=Absent. No evidence of awareness of restlessness; 1=Questionable. Non-specific inner tension and fidgety movements; 2=Mild akathisia. Awareness of restlessness in legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements not necessarily observed; 3=Moderate akathisia. Awareness of restlessness combined with characteristic restless movements; 4=Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace; 5=Severe akathisia. Strong compulsion to pace up and down most of the time. Constant restlessness associated with intense distress and insomnia. Higher scores indicated more akathisia.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
0.5  (0.83) 0.4  (0.68)
Change at Week 171 Number Analyzed 72 participants 2 participants
0.4  (0.79) 1.0  (1.41)
27.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171
Hide Description HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 79 participants 37 participants
2.7  (2.99) 4.3  (3.45)
Change at Week 171 Number Analyzed 7 participants 2 participants
1.3  (2.63) -2.5  (2.12)
28.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171
Hide Description HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
2.0  (2.47) 3.4  (2.54)
Change at Week 171 Number Analyzed 7 participants 2 participants
2.4  (5.26) 2.0  (4.24)
29.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171
Hide Description ESS is a self-administered questionnaire comprised of 8 questions that provides a measure of a participant’s general level of daytime sleepiness. Participants were asked to rate their usual chances of dozing off or falling asleep in different situations or activities that most people engage in as part of their daily lives (sitting and reading; watching TV; sitting inactive in a public place; as a passenger in a car for an hour without a break; lying down to rest in the afternoon when circumstances permit; sitting and talking to someone; sitting quietly after a lunch without alcohol; in a car, while stopped for a few minutes in traffic), on a 4-point Likert scale ranging from 0 to 3, where 0=no chance; 1=slight chance; 2=moderate chance; 3=high chance. Total ESS score is the sum of 8 item-scores and can range between 0 and 24 with a higher the score indicating a higher level of daytime sleepiness.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
4.4  (3.72) 6.0  (4.15)
Change at Week 171 Number Analyzed 7 participants 2 participants
4.7  (7.45) 1.0  (1.41)
30.Secondary Outcome
Title Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS is a clinician rated assessment of suicidal behavior and ideation categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior was reported.
Time Frame Baseline up to 1-week follow-up visit (up to approximately 3 years 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 81 37
Measure Type: Count of Participants
Unit of Measure: Participants
Suicidal Ideation
11
  13.6%
4
  10.8%
Suicidal Behavior
3
   3.7%
1
   2.7%
Self-injurious behavior without suicidal intent
1
   1.2%
0
   0.0%
31.Secondary Outcome
Title Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171
Hide Description MoCA is a validated rapid screening instrument for assessing mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation by using 30 questions test. Time to administer the MoCA© is approximately 10 minutes. The total possible score ranges from 0 (worst) to 30 (best) points; where higher scores indicate better cognitive function. A score of 26 or above is considered normal and a score below 26 is considered as recognitive dysfunction.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 80 participants 37 participants
23.9  (4.35) 21.9  (3.86)
Change at Week 171 Number Analyzed 7 participants 2 participants
-3.1  (4.81) 4.5  (3.54)
32.Secondary Outcome
Title Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Behavior Score at Week 171
Hide Description The UHDRS is a research tool developed by the Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. The total behavior score is made up of subscores evaluating depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations. For each subscore the frequency and severity was assessed separately. Frequency was rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity was rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment). Higher scores indicated greater behavioral impairments.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 80 participants 37 participants
7.1  (8.26) 10.9  (10.66)
Change at Week 171 Number Analyzed 7 participants 2 participants
8.6  (12.47) 4.5  (2.12)
33.Secondary Outcome
Title Change From Baseline in UHDRS Functional Assessment Score at Week 28
Hide Description The UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Functional assessment included 25 questions with possible answers ‘yes’ or ‘no’. Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 82 participants 37 participants
21.4  (3.00) 18.2  (4.94)
Change at Week 28 Number Analyzed 77 participants 34 participants
-1.6  (2.76) -1.6  (3.62)
34.Secondary Outcome
Title Change From Baseline in UHDRS Independence Scale Score at Week 28
Hide Description UHDRS: research tool to provide a uniform assessment of clinical features and course of HD. Components of UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Independence scale ranges from 10-100, indicating most accurate current level of participant’s independence. 10=Tube fed, total bed care; 20=No speech, must be fed; 30=Participant provides minimal assistance in own feeding,bathing,toileting; 40=Chronic care facility needed; limited self-feeding; 50=24-hour supervision appropriate; assistance required for bathing,eating,toileting; 60=Needs minor assistance in dressing,toileting,bathing; 70=Self-care maintained for bathing,limited household duties; unable to manage finances; 80=Pre-disease level of employment changes or ends; cannot perform household chores, may need help with finances; 90=No physical care needed(difficult tasks avoided); 100=No special care needed. Higher scores indicate better independence.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 82 participants 37 participants
84.0  (9.48) 75.5  (11.59)
Change at Week 28 Number Analyzed 77 participants 33 participants
-4.2  (9.60) -1.2  (8.93)
35.Secondary Outcome
Title Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132
Hide Description UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities (TFC). TFC is a 5-item clinician rating scale typically completed after a brief interview with a participant and/or collateral source. TFC globally assesses occupation, finances, domestic chores, activities of daily living, and level of care, with scores on each item ranging from 0 to either 2 or 3 (e.g., Occupation: 0 = unable, 1 = marginal work only, 2 = reduced capacity for usual job, 3 = normal). The five items are summed to yield a TFC total score, which ranges from 0 (normal function) to 13 (severe dysfunction). Higher scores indicated better functioning.
Time Frame Baseline, Week 132
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 82 participants 37 participants
9.6  (2.17) 8.3  (2.11)
Change at Week 132 Number Analyzed 57 participants 28 participants
-3.1  (2.86) -3.1  (2.71)
36.Secondary Outcome
Title Change From Baseline in UHDRS Cognitive Assessment Score at Week 171
Hide Description Components of UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale, total functional capacities. Cognitive assessment component:verbal fluency(VF) score (memory,attention)(requiring participant to generate as many words as possible beginning with a specific letter[F,A,S]in 60 seconds [sec]. Score[no range]:total number of correct words for 3 letters), symbol digit modalities test(SDMT) score(psychomotor speed,attention)(participant is required to pair digits to assigned symbols using a reference key. Score[0 {worst}-120 {best}]:total number of correct written responses in 90 sec), & Stroop interference(SI) score (selective attention,executive function)(includes 3 conditions:naming colour blocks[blue, red or green]; reading colour words printed in black ink; naming ink colour of incongruous colour words. For each condition score(no range)is number of correct responses produced in 45 sec). In these tests, higher scores reflect better cognitive ability.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
VF Score: Baseline Number Analyzed 80 participants 37 participants
25.1  (11.00) 21.5  (10.79)
VF Score: Change at Week 171 Number Analyzed 7 participants 2 participants
-10.9  (10.12) 4.0  (5.66)
SDMT: Baseline Number Analyzed 79 participants 34 participants
24.4  (8.91) 22.7  (17.38)
SDMT: Change at Week 171 Number Analyzed 7 participants 2 participants
-9.6  (7.04) 0.0  (7.07)
SI Score: Baseline Number Analyzed 80 participants 37 participants
3.2  (10.87) -0.5  (6.38)
SI Score: Change at Week 171 Number Analyzed 7 participants 2 participants
-2.4  (7.42) 6.5  (4.27)
37.Secondary Outcome
Title Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171
Hide Description UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes total motor score (TMS) and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0 (absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
12.04  (4.113) 12.46  (5.221)
Change at Week 171 Number Analyzed 7 participants 2 participants
-3.71  (7.544) 4.75  (1.061)
38.Secondary Outcome
Title Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171
Hide Description UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of clinical features and course of HD. Components of full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0(absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea. Data was measured and available for total safety population. Data was not available by individual cohorts (rollover cohort and switch cohort) from Week 8 to Week 171, as was done for change from baseline. Therefore, in order to present results data for this outcome measure, the total, combined safety population treatment arm was used.
Time Frame Week 8, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Combined Cohort (Rollover and Switch): SD-809 ER
Hide Arm/Group Description:
Participants of rollover cohort and switch cohort were included in this arm for the purpose of reporting data of this outcome measure.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 8 Number Analyzed 116 participants
8.5  (4.67)
Change at Week 171 Number Analyzed 9 participants
2.4  (5.00)
39.Secondary Outcome
Title Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171
Hide Description UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function.
Time Frame Baseline, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description:
Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
Overall Number of Participants Analyzed 82 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 78 participants 37 participants
34.67  (16.119) 37.76  (18.605)
Change at Week 171 Number Analyzed 7 participants 2 participants
11.29  (14.762) 18.50  (3.536)
40.Secondary Outcome
Title Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171
Hide Description Components of full UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale,total functional capacities. Motor function assessment includes TMS and TMC score. TMS assesses all motor features of HD and includes maximal chorea, maximal dystonia,ocular pursuit,saccade initiation and velocity,dysarthria,tongue protrusion,finger tapping,hand pronation and supination,luria rigidity,bradykinesia,gait,tandem walking,retropulsion pull test. Each of these was rated on a scale of 0(normal motor function) to 4(severely impaired motor function). TMS score is a sum of individual scores ranging from 0(normal motor function) to 124(severely impaired motor function). Lower TMS scores= better motor function. Data was available for total safety population, not by individual cohorts(rollover and switch cohort) from Week 8 to Week 171,as was done for change from baseline. Therefore, in order to present results data,the total,combined safety population treatment arm was used.
Time Frame Week 8, Week 171
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.
Arm/Group Title Combined Cohort (Rollover and Switch): SD-809 ER
Hide Arm/Group Description:
Participants of rollover cohort and switch cohort were included in this arm for the purpose of reporting data of this outcome measure.
Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 8 Number Analyzed 116 participants
30.7  (17.40)
Change at Week 171 Number Analyzed 9 participants
22.2  (12.02)
Time Frame Baseline to follow-up visit (up to approximately 3 years 9 months)
Adverse Event Reporting Description Safety population included all participants who received at least 1 dose of study drug.
 
Arm/Group Title Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Hide Arm/Group Description Participants who completed study SD-809-C-15 (either placebo group or SD-809 group, including 1-week washout period and Week 13 evaluation), received 6 mg SD-809 ER tablet once daily as a starting dose in this study. Dose titration was continued through Week 8 to optimize the dose. Dose of SD-809 ER could be adjusted weekly in increments of 6 mg/day (6 or 12 mg/day after a total daily dose of 48 mg was reached) based on chorea control and adverse events. Daily doses of SD-809 ER 12 mg and higher were administered twice daily. Maximum total daily dose of SD-809 ER was 72 mg/day (36 mg twice daily), unless the participant was receiving a strong CYP2D6 inhibitor (e.g., paroxetine, buproprion, and fluoxetine), in which case the maximum total daily dose was 42 mg (21 mg twice daily). Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States. Participants who were receiving FDA-approved dosing regimen of tetrabenazine for at least 8 weeks prior to screening, were converted overnight from their existing tetrabenazine regimen to SD-809 ER regimen to achieve targeted steady-state AUC of total (alpha+beta)-HTBZ metabolites that was predicted to be comparable to that of participant’s prior tetrabenazine regimen. Participants remained on initial dose of SD-809 ER through Week 1. Dose adjustment was continued through Week 4 to optimize the dose. Dose of SD-809 ER could be adjusted weekly (upward or downward) in increments of 6 mg per day (6 mg/day or 12 mg/day after a total daily dose of 48 mg was reached), based on chorea control and treatment regimen tolerability. Long-term treatment with SD-809 ER at a stable dose (although further dose adjustments were permitted, if clinically indicated) continued until SD-809 ER became commercially available in United States.
All-Cause Mortality
Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Affected / at Risk (%) Affected / at Risk (%)
Total   1/82 (1.22%)      0/37 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/82 (25.61%)      11/37 (29.73%)    
Gastrointestinal disorders     
Intestinal obstruction  1  0/82 (0.00%)  0 1/37 (2.70%)  1
General disorders     
Chest discomfort  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Sudden cardiac death  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Infections and infestations     
Actinomycotic pulmonary infection  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Appendicitis  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Cellulitis staphylococcal  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Gastroenteritis  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Infection  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Pneumonia  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Pyelonephritis acute  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Urinary tract infection bacterial  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/82 (1.22%)  1 1/37 (2.70%)  1
Head injury  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Hip fracture  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Subdural haematoma  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Upper limb fracture  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Investigations     
Weight decreased  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Metabolism and nutrition disorders     
Dehydration  1  2/82 (2.44%)  2 1/37 (2.70%)  1
Failure to thrive  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Penile cancer  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Renal oncocytoma  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Nervous system disorders     
Encephalopathy  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Lethargy  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Subarachnoid haemorrhage  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Syncope  1  1/82 (1.22%)  1 1/37 (2.70%)  1
Psychiatric disorders     
Aggression  1  1/82 (1.22%)  2 0/37 (0.00%)  0
Anxiety  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Depression  1  0/82 (0.00%)  0 1/37 (2.70%)  1
Depression suicidal  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Major depression  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Mental status changes  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Suicidal ideation  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Suicide attempt  1  2/82 (2.44%)  2 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Pulmonary embolism  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Surgical and medical procedures     
Spinal fusion surgery  1  1/82 (1.22%)  1 0/37 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/82 (1.22%)  1 0/37 (0.00%)  0
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rollover Cohort: SD-809 ER Switch Cohort: SD-809 ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/82 (90.24%)      32/37 (86.49%)    
Cardiac disorders     
Bradycardia  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Ear and labyrinth disorders     
Cerumen impaction  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Eye disorders     
Dry eye  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Gastrointestinal disorders     
Constipation  1  7/82 (8.54%)  7 5/37 (13.51%)  6
Diarrhoea  1  11/82 (13.41%)  13 7/37 (18.92%)  11
Dry mouth  1  4/82 (4.88%)  4 4/37 (10.81%)  4
Dysphagia  1  7/82 (8.54%)  12 6/37 (16.22%)  7
Gastrooesophageal reflux disease  1  1/82 (1.22%)  1 2/37 (5.41%)  2
Nausea  1  8/82 (9.76%)  8 3/37 (8.11%)  3
Vomiting  1  7/82 (8.54%)  10 2/37 (5.41%)  2
General disorders     
Chest pain  1  2/82 (2.44%)  2 2/37 (5.41%)  2
Fatigue  1  7/82 (8.54%)  8 2/37 (5.41%)  2
Gait disturbance  1  4/82 (4.88%)  5 2/37 (5.41%)  3
Irritability  1  11/82 (13.41%)  13 4/37 (10.81%)  5
Oedema peripheral  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Pyrexia  1  1/82 (1.22%)  1 2/37 (5.41%)  2
Infections and infestations     
Bronchitis  1  5/82 (6.10%)  5 2/37 (5.41%)  2
Nasopharyngitis  1  8/82 (9.76%)  11 6/37 (16.22%)  8
Pneumonia  1  1/82 (1.22%)  1 5/37 (13.51%)  5
Sinusitis  1  3/82 (3.66%)  3 2/37 (5.41%)  3
Upper respiratory tract infection  1  2/82 (2.44%)  2 2/37 (5.41%)  3
Urinary tract infection  1  12/82 (14.63%)  18 4/37 (10.81%)  5
Injury, poisoning and procedural complications     
Contusion  1  7/82 (8.54%)  11 1/37 (2.70%)  1
Fall  1  30/82 (36.59%)  78 15/37 (40.54%)  27
Laceration  1  7/82 (8.54%)  10 5/37 (13.51%)  9
Investigations     
Weight decreased  1  11/82 (13.41%)  12 8/37 (21.62%)  8
Metabolism and nutrition disorders     
Decreased appetite  1  1/82 (1.22%)  1 4/37 (10.81%)  5
Dehydration  1  3/82 (3.66%)  3 2/37 (5.41%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/82 (4.88%)  5 2/37 (5.41%)  3
Back pain  1  4/82 (4.88%)  4 2/37 (5.41%)  2
Nervous system disorders     
Akathisia  1  5/82 (6.10%)  5 4/37 (10.81%)  5
Balance disorder  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Chorea  1  7/82 (8.54%)  7 7/37 (18.92%)  10
Cognitive disorder  1  3/82 (3.66%)  4 2/37 (5.41%)  2
Headache  1  6/82 (7.32%)  7 1/37 (2.70%)  1
Memory impairment  1  3/82 (3.66%)  3 2/37 (5.41%)  2
Parkinsonism  1  3/82 (3.66%)  3 3/37 (8.11%)  4
Somnolence  1  16/82 (19.51%)  22 11/37 (29.73%)  16
Psychiatric disorders     
Agitation  1  3/82 (3.66%)  3 3/37 (8.11%)  3
Anxiety  1  22/82 (26.83%)  32 13/37 (35.14%)  14
Apathy  1  5/82 (6.10%)  6 1/37 (2.70%)  1
Depressed mood  1  0/82 (0.00%)  0 2/37 (5.41%)  3
Depression  1  26/82 (31.71%)  35 7/37 (18.92%)  8
Insomnia  1  19/82 (23.17%)  23 6/37 (16.22%)  7
Sleep disorder  1  5/82 (6.10%)  6 1/37 (2.70%)  1
Suicidal ideation  1  4/82 (4.88%)  6 2/37 (5.41%)  2
Renal and urinary disorders     
Micturition urgency  1  3/82 (3.66%)  3 2/37 (5.41%)  2
Pollakiuria  1  7/82 (8.54%)  7 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Choking  1  1/82 (1.22%)  1 3/37 (8.11%)  4
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  1/82 (1.22%)  1 2/37 (5.41%)  2
Hyperhidrosis  1  1/82 (1.22%)  1 2/37 (5.41%)  3
Pruritus  1  0/82 (0.00%)  0 2/37 (5.41%)  2
Rash  1  3/82 (3.66%)  4 2/37 (5.41%)  2
Vascular disorders     
Hypotension  1  0/82 (0.00%)  0 3/37 (8.11%)  3
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Auspex Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01897896     History of Changes
Other Study ID Numbers: SD-809-C-16
First Submitted: June 14, 2013
First Posted: July 12, 2013
Results First Submitted: January 28, 2019
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019