Trial Outcomes & Findings for 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 (NCT NCT02342548)

Last Updated: 2018-04-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

188 participants

Primary outcome timeframe

1 year

Results posted on

2018-04-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	20 mg PF-02545920 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.	5 mg PF-02545920 Titration up to 20 mg 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).	Placebo and Titration up to 20 mg PF-02545920 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 Study STARTED	51	71	66
Overall Study COMPLETED	17	9	23
Overall Study NOT COMPLETED	34	62	43

Reasons for withdrawal

Reasons for withdrawal
Measure	20 mg PF-02545920 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.	5 mg PF-02545920 Titration up to 20 mg 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).	Placebo and Titration up to 20 mg PF-02545920 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 Study Adverse Event	12	17	13
Overall Study Lost to Follow-up	0	1	0
Overall Study Study terminated by sponsor	20	39	25
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	1	3	4
Overall Study Other	1	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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 n=188 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 9.4 • n=5 Participants	48.4 years STANDARD_DEVIATION 8.6 • n=7 Participants	51.3 years STANDARD_DEVIATION 9.4 • n=5 Participants	49.9 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	33 Participants n=7 Participants	43 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	38 Participants n=7 Participants	23 Participants n=5 Participants	87 Participants n=4 Participants
Race/Ethnicity, Customized White	50 participants n=5 Participants	68 participants n=7 Participants	66 participants n=5 Participants	184 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events AEs	39 Participants	63 Participants	62 Participants
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events SAEs	7 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	19 Participants	27 Participants	28 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine SBP <90 mmHg	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing SBP <90 mmHg	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine DBP <50 mmHg	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing DBP <50 mmHg	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine pulse rate <40 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine pulse rate >120 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing pulse rate <40 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing pulse rate >140 bpm	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine SBP increase from baseline >=30 mmHg	3 Participants	1 Participants	6 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing SBP increase from baseline >=30 mmHg	1 Participants	6 Participants	4 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine DBP increase from baseline >=20 mmHg	4 Participants	2 Participants	6 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing DBP increase from baseline >=20 mmHg	3 Participants	8 Participants	2 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine SBP decrease from baseline >=30 mmHg	2 Participants	1 Participants	4 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing SBP decrease from baseline >=30 mmHg	0 Participants	1 Participants	2 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Supine DBP decrease from baseline >=20 mmHg	0 Participants	2 Participants	7 Participants
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria Standing DBP decrease from baseline >=20 mmHg	1 Participants	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria PR interval >=300 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QRS complex >=140 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QTcF interval: 450 to <480 msec	2 Participants	2 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QTcF interval: 480 to <500 msec	0 Participants	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QTcF interval >=500 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria PR interval increase from baseline >=25/50 percent	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QRS complex increase from baseline >=50 percent	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QTcF increase from baseline: 30 to <60 msec	3 Participants	5 Participants	4 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria QTcF increase from baseline >=60 msec	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=65 Participants 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).
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) ANC < 0.8*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) WBC < 0.6*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) WBC > 1.5*ULN	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality) ANC > 1.2*ULN	3 Participants	4 Participants	7 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Laboratory Test Abnormalities (Normal Baseline)	13 Participants	22 Participants	23 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Severe dyskinesia	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Mild dystonia	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Moderate dystonia	0 Participants	1 Participants	1 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Severe dystonia	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Mild akathisia	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Moderate akathisia	0 Participants	1 Participants	3 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Severe akathisia	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Mild dyskinesia	0 Participants	2 Participants	4 Participants
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity Moderate dyskinesia	1 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=51 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=71 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 Participants 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).
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Day 1: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Day 1: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Day 1: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Day 1: suicidal ideation	0 Participants	1 Participants	1 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Day 1: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 2: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 2: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 2: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 2: suicidal ideation	0 Participants	0 Participants	1 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 2: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 4: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 4: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 4: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 4: suicidal ideation	0 Participants	1 Participants	1 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Week 4: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 3: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 3: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 3: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 3: suicidal ideation	1 Participants	0 Participants	1 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 3: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 6: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 6: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 6: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 6: suicidal ideation	1 Participants	0 Participants	1 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 6: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 9: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 9: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 9: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 9: suicidal ideation	0 Participants	1 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 9: self-injurious behavior	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 12: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 12: suicide attempt	1 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 12: preparatory acts towards suicide	1 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 12: suicidal ideation	3 Participants	0 Participants	3 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Month 12: self-injurious behavior	1 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Follow up: completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Follow up: suicide attempt	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Follow up: preparatory acts towards suicide	0 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Follow up: suicidal ideation	1 Participants	0 Participants	0 Participants
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category Follow up: self-injurious behavior	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Month 6, and Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=50 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=70 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=62 Participants 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).
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score Month 6	2.4 units on a scale Standard Deviation 7.21	3.5 units on a scale Standard Deviation 7.61	0.7 units on a scale Standard Deviation 7.43
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score Month 12	4.9 units on a scale Standard Deviation 10.17	3.3 units on a scale Standard Deviation 6.71	0.6 units on a scale Standard Deviation 8.24

SECONDARY outcome

Timeframe: Baseline (Day 1), Month 6, and Month 12

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=50 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=70 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=62 Participants 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).
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score Month 6	0.1 Units on a scale Standard Deviation 3.12	1.3 Units on a scale Standard Deviation 3.97	1.4 Units on a scale Standard Deviation 4.14
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score Month 12	0.1 Units on a scale Standard Deviation 4.92	0.8 Units on a scale Standard Deviation 1.64	0.7 Units on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Month 6 and Month 12

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.

Outcome measures

Outcome measures
Measure	20 mg PF-02545920 n=50 Participants 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.	5 mg PF-02545920 Titration up to 20 mg n=70 Participants 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).	Placebo and Titration up to 20 mg PF-02545920 n=62 Participants 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).
Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score Month 6	3.9 units on a scale Standard Deviation 1.04	4.2 units on a scale Standard Deviation 1.03	3.7 units on a scale Standard Deviation 1.19
Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score Month 12	3.5 units on a scale Standard Deviation 1.30	4.6 units on a scale Standard Deviation 1.13	4.0 units on a scale Standard Deviation 1.21

Adverse Events

20 mg PF-02545920

Serious events: 7 serious events

Other events: 32 other events

Deaths: 0 deaths

5 mg PF-02545920 Titration up to 20 mg

Serious events: 9 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo and Titration up to 20 mg PF-02545920

Serious events: 5 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	20 mg PF-02545920 n=51 participants at risk 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.	5 mg PF-02545920 Titration up to 20 mg n=71 participants at risk 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 participants at risk 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).
Congenital, familial and genetic disorders Huntington's disease	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Gastrointestinal disorders Dysphagia	0.00% 0/51 • 1 year	0.00% 0/71 • 1 year	1.5% 1/66 • 1 year
Gastrointestinal disorders Pancreatitis	0.00% 0/51 • 1 year	0.00% 0/71 • 1 year	1.5% 1/66 • 1 year
General disorders Complication associated with device	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Hepatobiliary disorders Cholelithiasis	0.00% 0/51 • 1 year	0.00% 0/71 • 1 year	1.5% 1/66 • 1 year
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Injury, poisoning and procedural complications Fall	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	1.5% 1/66 • 1 year
Investigations Blood creatine phosphokinase increased	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Investigations Weight decreased	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Metabolism and nutrition disorders Dehydration	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Musculoskeletal and connective tissue disorders Osteoarthritis	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Nervous system disorders Chorea	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Nervous system disorders Hyperkinesia	3.9% 2/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Nervous system disorders Syncope	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	1.5% 1/66 • 1 year
Nervous system disorders Transient ischaemic attack	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Psychiatric disorders Agitation	0.00% 0/51 • 1 year	0.00% 0/71 • 1 year	1.5% 1/66 • 1 year
Psychiatric disorders Depression	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Psychiatric disorders Panic attack	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Psychiatric disorders Suicide attempt	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Renal and urinary disorders Urinary tract disorder	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year
Reproductive system and breast disorders Prostatomegaly	2.0% 1/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/51 • 1 year	1.4% 1/71 • 1 year	0.00% 0/66 • 1 year

Other adverse events

Other adverse events
Measure	20 mg PF-02545920 n=51 participants at risk 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.	5 mg PF-02545920 Titration up to 20 mg n=71 participants at risk 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).	Placebo and Titration up to 20 mg PF-02545920 n=66 participants at risk 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).
Gastrointestinal disorders Diarrhoea	3.9% 2/51 • 1 year	8.5% 6/71 • 1 year	6.1% 4/66 • 1 year
Gastrointestinal disorders Dysphagia	3.9% 2/51 • 1 year	4.2% 3/71 • 1 year	6.1% 4/66 • 1 year
Gastrointestinal disorders Nausea	3.9% 2/51 • 1 year	12.7% 9/71 • 1 year	12.1% 8/66 • 1 year
Gastrointestinal disorders Vomiting	2.0% 1/51 • 1 year	7.0% 5/71 • 1 year	4.5% 3/66 • 1 year
General disorders Fatigue	3.9% 2/51 • 1 year	12.7% 9/71 • 1 year	13.6% 9/66 • 1 year
Infections and infestations Viral upper respiratory tract infection	7.8% 4/51 • 1 year	4.2% 3/71 • 1 year	10.6% 7/66 • 1 year
Injury, poisoning and procedural complications Fall	11.8% 6/51 • 1 year	21.1% 15/71 • 1 year	12.1% 8/66 • 1 year
Investigations Weight decreased	5.9% 3/51 • 1 year	9.9% 7/71 • 1 year	16.7% 11/66 • 1 year
Musculoskeletal and connective tissue disorders Back pain	5.9% 3/51 • 1 year	8.5% 6/71 • 1 year	6.1% 4/66 • 1 year
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 3/51 • 1 year	0.00% 0/71 • 1 year	0.00% 0/66 • 1 year
Nervous system disorders Akathisia	2.0% 1/51 • 1 year	2.8% 2/71 • 1 year	6.1% 4/66 • 1 year
Nervous system disorders Chorea	21.6% 11/51 • 1 year	15.5% 11/71 • 1 year	21.2% 14/66 • 1 year
Nervous system disorders Dizziness	0.00% 0/51 • 1 year	12.7% 9/71 • 1 year	7.6% 5/66 • 1 year
Nervous system disorders Dyskinesia	2.0% 1/51 • 1 year	4.2% 3/71 • 1 year	9.1% 6/66 • 1 year
Nervous system disorders Headache	2.0% 1/51 • 1 year	7.0% 5/71 • 1 year	4.5% 3/66 • 1 year
Nervous system disorders Hyperkinesia	13.7% 7/51 • 1 year	0.00% 0/71 • 1 year	3.0% 2/66 • 1 year
Nervous system disorders Sedation	2.0% 1/51 • 1 year	2.8% 2/71 • 1 year	7.6% 5/66 • 1 year
Nervous system disorders Somnolence	2.0% 1/51 • 1 year	5.6% 4/71 • 1 year	13.6% 9/66 • 1 year
Psychiatric disorders Anxiety	3.9% 2/51 • 1 year	7.0% 5/71 • 1 year	10.6% 7/66 • 1 year
Psychiatric disorders Depression	5.9% 3/51 • 1 year	4.2% 3/71 • 1 year	7.6% 5/66 • 1 year
Psychiatric disorders Insomnia	3.9% 2/51 • 1 year	5.6% 4/71 • 1 year	13.6% 9/66 • 1 year
Psychiatric disorders Restlessness	2.0% 1/51 • 1 year	2.8% 2/71 • 1 year	7.6% 5/66 • 1 year
Psychiatric disorders Sleep disorder	5.9% 3/51 • 1 year	4.2% 3/71 • 1 year	3.0% 2/66 • 1 year

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER