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Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021

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ClinicalTrials.gov Identifier: NCT02342548
Recruitment Status : Terminated (Study terminated on 15DEC2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 & placebo. No safety concerns.)
First Posted : January 21, 2015
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Huntington's Disease
Intervention Drug: 20 mg BID of PF-02545920
Enrollment 188
Recruitment Details  
Pre-assignment Details This was an open-label extension study conducted in participants who had completed study A8241021 (NCT02197130). Treatment assignment was double-blinded from Day 1 to Day 21, and became open-label from Day 22, since all participants began receiving the same dose level from Day 22.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time. Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets). Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Period Title: Overall Study
Started 51 71 66
Completed 17 9 23
Not Completed 34 62 43
Reason Not Completed
Adverse Event             12             17             13
Lost to Follow-up             0             1             0
Study terminated by sponsor             20             39             25
Protocol Violation             0             1             0
Withdrawal by Subject             1             3             4
Other             1             1             1
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920 Total
Hide Arm/Group Description Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time. Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets). Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets). Total of all reporting groups
Overall Number of Baseline Participants 51 71 66 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 71 participants 66 participants 188 participants
50.2  (9.4) 48.4  (8.6) 51.3  (9.4) 49.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 71 participants 66 participants 188 participants
Female
25
  49.0%
33
  46.5%
43
  65.2%
101
  53.7%
Male
26
  51.0%
38
  53.5%
23
  34.8%
87
  46.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 71 participants 66 participants 188 participants
White 50 68 66 184
Other 1 3 0 4
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
39
  76.5%
63
  88.7%
62
  93.9%
SAEs
7
  13.7%
9
  12.7%
5
   7.6%
2.Primary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hide Description The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
19
  37.3%
27
  38.0%
28
  42.4%
3.Primary Outcome
Title Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Hide Description Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); (2) standing SBP <90 mmHg; (3) supine diastolic blood pressure (DBP) <50 mmHg; (4) standing DBP <50 mmHg; (5) supine pulse rate <40 beats per minute (bpm); (6) supine pulse rate >120 bpm; (7) standing pulse rate <40 bpm; (8) standing pulse rate >140 bpm; (9) maximum increase from baseline in supine SBP >= 30 mmHg; (10) maximum increase from baseline in standing SBP >= 30 mmHg; (11) maximum increase from baseline in supine DBP >= 20 mmHg; (12) maximum increase from baseline in standing DBP >= 20 mmHg; (13) maximum decrease from baseline in supine SBP >=30 mmHg; (14) maximum decrease from baseline in standing SBP >=30 mmHg; (15) maximum decrease from baseline in supine DBP >=20 mmHg; (16) maximum decrease from baseline in standing DBP >=20 mmHg.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
Supine SBP <90 mmHg Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Standing SBP <90 mmHg Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
1
   1.4%
0
   0.0%
Supine DBP <50 mmHg Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
1
   1.4%
0
   0.0%
Standing DBP <50 mmHg Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
1
   1.4%
0
   0.0%
Supine pulse rate <40 bpm Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Supine pulse rate >120 bpm Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Standing pulse rate <40 bpm Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Standing pulse rate >140 bpm Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Supine SBP increase from baseline >=30 mmHg Number Analyzed 49 participants 69 participants 65 participants
3
   6.1%
1
   1.4%
6
   9.2%
Standing SBP increase from baseline >=30 mmHg Number Analyzed 48 participants 69 participants 64 participants
1
   2.1%
6
   8.7%
4
   6.3%
Supine DBP increase from baseline >=20 mmHg Number Analyzed 49 participants 69 participants 65 participants
4
   8.2%
2
   2.9%
6
   9.2%
Standing DBP increase from baseline >=20 mmHg Number Analyzed 48 participants 69 participants 64 participants
3
   6.3%
8
  11.6%
2
   3.1%
Supine SBP decrease from baseline >=30 mmHg Number Analyzed 49 participants 69 participants 65 participants
2
   4.1%
1
   1.4%
4
   6.2%
Standing SBP decrease from baseline >=30 mmHg Number Analyzed 48 participants 69 participants 64 participants
0
   0.0%
1
   1.4%
2
   3.1%
Supine DBP decrease from baseline >=20 mmHg Number Analyzed 49 participants 69 participants 65 participants
0
   0.0%
2
   2.9%
7
  10.8%
Standing DBP decrease from baseline >=20 mmHg Number Analyzed 48 participants 69 participants 64 participants
1
   2.1%
4
   5.8%
6
   9.4%
4.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
Hide Description Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval increase from baseline >=25/50 percent; (7) QRS complex increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
PR interval >=300 msec Number Analyzed 50 participants 69 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
QRS complex >=140 msec Number Analyzed 50 participants 69 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
QTcF interval: 450 to <480 msec Number Analyzed 50 participants 69 participants 66 participants
2
   4.0%
2
   2.9%
2
   3.0%
QTcF interval: 480 to <500 msec Number Analyzed 50 participants 69 participants 66 participants
0
   0.0%
0
   0.0%
1
   1.5%
QTcF interval >=500 msec Number Analyzed 50 participants 69 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
PR interval increase from baseline >=25/50 percent Number Analyzed 50 participants 66 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
QRS complex increase from baseline >=50 percent Number Analyzed 50 participants 66 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
QTcF increase from baseline: 30 to <60 msec Number Analyzed 50 participants 66 participants 66 participants
3
   6.0%
5
   7.6%
4
   6.1%
QTcF increase from baseline >=60 msec Number Analyzed 50 participants 66 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)
Hide Description Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count <0.6 *the lower limit of normal (LLN); (2) WBC count >1.5 times the upper limit of normal (ULN); (3) ANC <0.8*LLN; and (4) ANC >1.2*ULN.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 65
Measure Type: Count of Participants
Unit of Measure: Participants
WBC < 0.6*LLN
0
   0.0%
0
   0.0%
0
   0.0%
WBC > 1.5*ULN
1
   2.0%
0
   0.0%
1
   1.5%
ANC < 0.8*LLN
1
   2.0%
0
   0.0%
0
   0.0%
ANC > 1.2*ULN
3
   5.9%
4
   5.6%
7
  10.8%
6.Primary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Normal Baseline)
Hide Description The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
13
  25.5%
22
  31.0%
23
  34.8%
7.Primary Outcome
Title Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity
Hide Description Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
Mild dystonia
0
   0.0%
1
   1.4%
0
   0.0%
Moderate dystonia
0
   0.0%
1
   1.4%
1
   1.5%
Severe dystonia
0
   0.0%
0
   0.0%
0
   0.0%
Mild akathisia
1
   2.0%
1
   1.4%
0
   0.0%
Moderate akathisia
0
   0.0%
1
   1.4%
3
   4.5%
Severe akathisia
0
   0.0%
0
   0.0%
1
   1.5%
Mild dyskinesia
0
   0.0%
2
   2.8%
4
   6.1%
Moderate dyskinesia
1
   2.0%
1
   1.4%
2
   3.0%
Severe dyskinesia
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category
Hide Description Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).
Time Frame Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 time point.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 51 71 66
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1: completed suicide Number Analyzed 51 participants 71 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
Day 1: suicide attempt Number Analyzed 51 participants 71 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
Day 1: preparatory acts towards suicide Number Analyzed 51 participants 71 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
Day 1: suicidal ideation Number Analyzed 51 participants 71 participants 66 participants
0
   0.0%
1
   1.4%
1
   1.5%
Day 1: self-injurious behavior Number Analyzed 51 participants 71 participants 66 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 2: completed suicide Number Analyzed 51 participants 69 participants 64 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 2: suicide attempt Number Analyzed 51 participants 69 participants 64 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 2: preparatory acts towards suicide Number Analyzed 51 participants 69 participants 64 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 2: suicidal ideation Number Analyzed 51 participants 69 participants 64 participants
0
   0.0%
0
   0.0%
1
   1.6%
Week 2: self-injurious behavior Number Analyzed 51 participants 69 participants 64 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 4: completed suicide Number Analyzed 50 participants 66 participants 63 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 4: suicide attempt Number Analyzed 50 participants 66 participants 63 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 4: preparatory acts towards suicide Number Analyzed 50 participants 66 participants 63 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 4: suicidal ideation Number Analyzed 50 participants 66 participants 63 participants
0
   0.0%
1
   1.5%
1
   1.6%
Week 4: self-injurious behavior Number Analyzed 50 participants 66 participants 63 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 3: completed suicide Number Analyzed 42 participants 61 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 3: suicide attempt Number Analyzed 42 participants 61 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 3: preparatory acts towards suicide Number Analyzed 42 participants 61 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 3: suicidal ideation Number Analyzed 42 participants 61 participants 57 participants
1
   2.4%
0
   0.0%
1
   1.8%
Month 3: self-injurious behavior Number Analyzed 42 participants 61 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 6: completed suicide Number Analyzed 35 participants 37 participants 42 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 6: suicide attempt Number Analyzed 35 participants 37 participants 42 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 6: preparatory acts towards suicide Number Analyzed 35 participants 37 participants 42 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 6: suicidal ideation Number Analyzed 35 participants 37 participants 42 participants
1
   2.9%
0
   0.0%
1
   2.4%
Month 6: self-injurious behavior Number Analyzed 35 participants 37 participants 42 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 9: completed suicide Number Analyzed 26 participants 20 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 9: suicide attempt Number Analyzed 26 participants 20 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 9: preparatory acts towards suicide Number Analyzed 26 participants 20 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 9: suicidal ideation Number Analyzed 26 participants 20 participants 29 participants
0
   0.0%
1
   5.0%
0
   0.0%
Month 9: self-injurious behavior Number Analyzed 26 participants 20 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 12: completed suicide Number Analyzed 48 participants 69 participants 65 participants
0
   0.0%
0
   0.0%
0
   0.0%
Month 12: suicide attempt Number Analyzed 48 participants 69 participants 65 participants
1
   2.1%
0
   0.0%
0
   0.0%
Month 12: preparatory acts towards suicide Number Analyzed 48 participants 69 participants 65 participants
1
   2.1%
0
   0.0%
0
   0.0%
Month 12: suicidal ideation Number Analyzed 48 participants 69 participants 65 participants
3
   6.3%
0
   0.0%
3
   4.6%
Month 12: self-injurious behavior Number Analyzed 48 participants 69 participants 65 participants
1
   2.1%
0
   0.0%
0
   0.0%
Follow up: completed suicide Number Analyzed 23 participants 13 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Follow up: suicide attempt Number Analyzed 23 participants 13 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Follow up: preparatory acts towards suicide Number Analyzed 23 participants 13 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Follow up: suicidal ideation Number Analyzed 23 participants 13 participants 26 participants
1
   4.3%
0
   0.0%
0
   0.0%
Follow up: self-injurious behavior Number Analyzed 23 participants 13 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score
Hide Description The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington’s disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.
Time Frame Baseline (Day 1), Month 6, and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 50 70 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 6 Number Analyzed 33 participants 39 participants 40 participants
2.4  (7.21) 3.5  (7.61) 0.7  (7.43)
Month 12 Number Analyzed 15 participants 9 participants 22 participants
4.9  (10.17) 3.3  (6.71) 0.6  (8.24)
10.Secondary Outcome
Title Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score
Hide Description The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington’s disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms.
Time Frame Baseline (Day 1), Month 6, and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 50 70 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Month 6 Number Analyzed 33 participants 39 participants 40 participants
0.1  (3.12) 1.3  (3.97) 1.4  (4.14)
Month 12 Number Analyzed 15 participants 9 participants 22 participants
0.1  (4.92) 0.8  (1.64) 0.7  (3.51)
11.Secondary Outcome
Title Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score
Hide Description The Clinical Global Impression of Improvement (CGI-I) is a global measure of improvement or change based on the clinician’s assessment of all available clinical data obtained from interviewing the participant. The CGI-I consists of a single 7-point rating of total improvement or change from baseline severity, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, “Compared to your participant’s condition at the beginning of treatment, how much has he/she changed?” Scores are: 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse.
Time Frame Month 6 and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description:
Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Overall Number of Participants Analyzed 50 70 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 6 Number Analyzed 33 participants 39 participants 41 participants
3.9  (1.04) 4.2  (1.03) 3.7  (1.19)
Month 12 Number Analyzed 15 participants 9 participants 22 participants
3.5  (1.30) 4.6  (1.13) 4.0  (1.21)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Hide Arm/Group Description Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time. Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets). Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
All-Cause Mortality
20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/71 (0.00%)   0/66 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/51 (13.73%)   9/71 (12.68%)   5/66 (7.58%) 
Congenital, familial and genetic disorders       
Huntington's disease * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Gastrointestinal disorders       
Dysphagia * 1  0/51 (0.00%)  0/71 (0.00%)  1/66 (1.52%) 
Pancreatitis * 1  0/51 (0.00%)  0/71 (0.00%)  1/66 (1.52%) 
General disorders       
Complication associated with device * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  0/51 (0.00%)  0/71 (0.00%)  1/66 (1.52%) 
Injury, poisoning and procedural complications       
Cervical vertebral fracture * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Fall * 1  0/51 (0.00%)  1/71 (1.41%)  1/66 (1.52%) 
Investigations       
Blood creatine phosphokinase increased * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Weight decreased * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Intervertebral disc protrusion * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Osteoarthritis * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Nervous system disorders       
Chorea * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Hyperkinesia * 1  2/51 (3.92%)  0/71 (0.00%)  0/66 (0.00%) 
Syncope * 1  0/51 (0.00%)  1/71 (1.41%)  1/66 (1.52%) 
Transient ischaemic attack * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Psychiatric disorders       
Agitation * 1  0/51 (0.00%)  0/71 (0.00%)  1/66 (1.52%) 
Depression * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Panic attack * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Suicide attempt * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Renal and urinary disorders       
Urinary tract disorder * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
Reproductive system and breast disorders       
Prostatomegaly * 1  1/51 (1.96%)  0/71 (0.00%)  0/66 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/51 (0.00%)  1/71 (1.41%)  0/66 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
20 mg PF-02545920 5 mg PF-02545920 Titration up to 20 mg Placebo and Titration up to 20 mg PF-02545920
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/51 (62.75%)   53/71 (74.65%)   54/66 (81.82%) 
Gastrointestinal disorders       
Diarrhoea * 1  2/51 (3.92%)  6/71 (8.45%)  4/66 (6.06%) 
Dysphagia * 1  2/51 (3.92%)  3/71 (4.23%)  4/66 (6.06%) 
Nausea * 1  2/51 (3.92%)  9/71 (12.68%)  8/66 (12.12%) 
Vomiting * 1  1/51 (1.96%)  5/71 (7.04%)  3/66 (4.55%) 
General disorders       
Fatigue * 1  2/51 (3.92%)  9/71 (12.68%)  9/66 (13.64%) 
Infections and infestations       
Viral upper respiratory tract infection * 1  4/51 (7.84%)  3/71 (4.23%)  7/66 (10.61%) 
Injury, poisoning and procedural complications       
Fall * 1  6/51 (11.76%)  15/71 (21.13%)  8/66 (12.12%) 
Investigations       
Weight decreased * 1  3/51 (5.88%)  7/71 (9.86%)  11/66 (16.67%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  3/51 (5.88%)  6/71 (8.45%)  4/66 (6.06%) 
Muscle spasms * 1  3/51 (5.88%)  0/71 (0.00%)  0/66 (0.00%) 
Nervous system disorders       
Akathisia * 1  1/51 (1.96%)  2/71 (2.82%)  4/66 (6.06%) 
Chorea * 1  11/51 (21.57%)  11/71 (15.49%)  14/66 (21.21%) 
Dizziness * 1  0/51 (0.00%)  9/71 (12.68%)  5/66 (7.58%) 
Dyskinesia * 1  1/51 (1.96%)  3/71 (4.23%)  6/66 (9.09%) 
Headache * 1  1/51 (1.96%)  5/71 (7.04%)  3/66 (4.55%) 
Hyperkinesia * 1  7/51 (13.73%)  0/71 (0.00%)  2/66 (3.03%) 
Sedation * 1  1/51 (1.96%)  2/71 (2.82%)  5/66 (7.58%) 
Somnolence * 1  1/51 (1.96%)  4/71 (5.63%)  9/66 (13.64%) 
Psychiatric disorders       
Anxiety * 1  2/51 (3.92%)  5/71 (7.04%)  7/66 (10.61%) 
Depression * 1  3/51 (5.88%)  3/71 (4.23%)  5/66 (7.58%) 
Insomnia * 1  2/51 (3.92%)  4/71 (5.63%)  9/66 (13.64%) 
Restlessness * 1  1/51 (1.96%)  2/71 (2.82%)  5/66 (7.58%) 
Sleep disorder * 1  3/51 (5.88%)  3/71 (4.23%)  2/66 (3.03%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
This study was terminated on 15 December 2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 and placebo. No safety concerns were associated with this termination.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02342548     History of Changes
Other Study ID Numbers: A8241022
2014-004900-31 ( EudraCT Number )
OPEN LABEL TO A8241021 ( Other Identifier: Alias Study Number )
First Submitted: January 15, 2015
First Posted: January 21, 2015
Results First Submitted: February 2, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018