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First Time Use of SD-809 in Huntington Disease (First-HD)

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ClinicalTrials.gov Identifier: NCT01795859
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : August 11, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chorea
Interventions Drug: SD-809
Drug: Placebo
Enrollment 90

Recruitment Details A total of 90 subjects were randomized 1:1 to receive either SD-809 or placebo. All subjects were assessed for capacity to provide informed consent and written informed consent was obtained appropriately
Pre-assignment Details  
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Period Title: Overall Study
Started 45 45
Completed 44 43
Not Completed 1 2
Arm/Group Title SD-809 Tablets SD-809 Placebo Total
Hide Arm/Group Description SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). Placebo: Placebo tablets are identical in appearance to SD-809 tablets. Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Participants
SD-809 Number Analyzed 45 participants 45 participants 90 participants
55.4  (10.32) 52.1  (13.36) 53.7  (11.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
23
  51.1%
17
  37.8%
40
  44.4%
Male
22
  48.9%
28
  62.2%
50
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
5
  11.1%
5
   5.6%
White
45
 100.0%
38
  84.4%
83
  92.2%
More than one race
0
   0.0%
2
   4.4%
2
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Hide Description Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Time Frame Screening, Day 0, Weeks 9, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description:
SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.42  (2.953) -1.93  (2.666)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SD-809 Tablets, SD-809 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.49
Confidence Interval (2-Sided) 95%
-3.69 to -1.29
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
Hide Description A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment.
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description:
SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Number of Participants Analyzed 45 45
Measure Type: Count of Participants
Unit of Measure: Participants
23
  51.1%
9
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SD-809 Tablets, SD-809 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Difference of proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.1
Confidence Interval (2-Sided) 95%
12.4 to 49.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
Hide Description A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment.
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description:
SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Number of Participants Analyzed 45 45
Measure Type: Count of Participants
Unit of Measure: Participants
19
  42.2%
6
  13.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SD-809 Tablets, SD-809 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Difference of proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.9
Confidence Interval (2-Sided) 95%
11.4 to 46.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
Hide Description Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description:
SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Number of Participants Analyzed 45 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.74  (9.773) -3.61  (9.669)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SD-809 Tablets, SD-809 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0308
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 4.34
Confidence Interval (2-Sided) 95%
0.41 to 8.27
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Berg Balance Test (BBT)
Hide Description The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used
Arm/Group Title SD-809 Tablets SD-809 Placebo
Hide Arm/Group Description:
SD-809: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Number of Participants Analyzed 45 45
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
2.2  (3.47) 1.3  (4.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SD-809 Tablets, SD-809 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1415
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.3 to 2.3
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo SD-809
Hide Arm/Group Description Placebo SD-809
All-Cause Mortality
Placebo SD-809
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SD-809
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/45 (2.22%)      1/45 (2.22%)    
Hepatobiliary disorders     
Cholecystitis chronic   0/45 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders     
Agitated depression   0/45 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   1/45 (2.22%)  1 0/45 (0.00%)  0
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%
Placebo SD-809
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/45 (46.67%)      18/45 (40.00%)    
Gastrointestinal disorders     
Diarrhoea   0/45 (0.00%)  0 4/45 (8.89%)  4
Dry mouth   3/45 (6.67%)  3 4/45 (8.89%)  4
Vomiting   3/45 (6.67%)  3 0/45 (0.00%)  0
General disorders     
Fatigue   2/45 (4.44%)  2 3/45 (6.67%)  4
Irritability   6/45 (13.33%)  6 3/45 (6.67%)  3
Injury, poisoning and procedural complications     
Fall   4/45 (8.89%)  6 2/45 (4.44%)  4
Nervous system disorders     
Dizziness   4/45 (8.89%)  4 2/45 (4.44%)  2
Headache   3/45 (6.67%)  3 0/45 (0.00%)  0
Somnolence   2/45 (4.44%)  2 5/45 (11.11%)  6
Psychiatric disorders     
Depression   3/45 (6.67%)  3 1/45 (2.22%)  1
Insomnia   2/45 (4.44%)  2 3/45 (6.67%)  3
Sleep disorder   3/45 (6.67%)  3 0/45 (0.00%)  0
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.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 215-591-3000
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Huntington Study Group, Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, Kinel S, Leavitt B, Oakes D, O'Neill C, Vaughan C, Goldstein J, Herzog M, Snively V, Whaley J, Wong C, Suter G, Jankovic J, Jimenez-Shahed J, Hunter C, Claassen DO, Roman OC, Sung V, Smith J, Janicki S, Clouse R, Saint-Hilaire M, Hohler A, Turpin D, James RC, Rodriguez R, Rizer K, Anderson KE, Heller H, Carlson A, Criswell S, Racette BA, Revilla FJ, Nucifora F Jr, Margolis RL, Ong M, Mendis T, Mendis N, Singer C, Quesada M, Paulsen JS, Brashers-Krug T, Miller A, Kerr J, Dubinsky RM, Gray C, Factor SA, Sperin E, Molho E, Eglow M, Evans S, Kumar R, Reeves C, Samii A, Chouinard S, Beland M, Scott BL, Hickey PT, Esmail S, Fung WL, Gibbons C, Qi L, Colcher A, Hackmyer C, McGarry A, Klos K, Gudesblatt M, Fafard L, Graffitti L, Schneider DP, Dhall R, Wojcieszek JM, LaFaver K, Duker A, Neefus E, Wilson-Perez H, Shprecher D, Wall P, Blindauer KA, Wheeler L, Boyd JT, Houston E, Farbman ES, Agarwal P, Eberly SW, Watts A, Tariot PN, Feigin A, Evans S, Beck C, Orme C, Edicola J, Christopher E. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. doi: 10.1001/jama.2016.8655.
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01795859     History of Changes
Other Study ID Numbers: SD-809-C-15
First Submitted: February 20, 2013
First Posted: February 21, 2013
Results First Submitted: May 5, 2017
Results First Posted: August 11, 2017
Last Update Posted: September 20, 2017