A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 108
- 试验地点
- 55
- 主要终点
- Change From Baseline in Daily OFF Time at Week 10
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.
详细描述
The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.
- •Clinical diagnosis of Parkinson's disease.
- •Able to refrain from any Parkinson's disease medication not permitted by the protocol.
排除标准
- •Female of childbearing potential
- •History or presence of atypical Parkinsonian syndrome.
- •History of surgical intervention for Parkinson's disease.
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
- •Any condition possibly affecting drug absorption.
- •Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
PF-06649751 low dose (1 mg QD)
PF-06649751 low dose level (1 mg QD)
干预措施: PF-06649751 low dose (1 mg QD) (Drug)
PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 lower middle dose 1 (3 mg QD)
干预措施: PF-06649751 middle dose 1 (3 mg QD) (Drug)
PF-06649751 middle dose 2 (7 mg QD)
PF-06649751 higher middle dose 2 (7 mg QD)
干预措施: PF-06649751 middle dose 2 (7 mg QD) (Drug)
PF-06649751 high dose (15 mg QD)
PF-06649751 high dose (15 mg QD)
干预措施: PF-06649751 high dose (15 mg QD) (Drug)
结局指标
主要结局
Change From Baseline in Daily OFF Time at Week 10
时间窗: Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).
A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit.
次要结局
- Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III(Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement)
- Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality(Baseline (Day 0) to Week 17)
- Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)(Baseline (Day 0) and Weeks 5, 10 and 15)
- Change From Baseline in Daily ON Time With Troublesome Dyskinesia(Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).)
- Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization(Baseline (Day 0) to Week 17)
- Change From Baseline in Daily OFF Time(Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).)
- Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score(Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths(Day 1 to follow-up (Week 19 visit))
- Change From Baseline in Daily ON Time Without Troublesome Dyskinesia(Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0))
- Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization(Baseline (Day 0) to Week 17)
- Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits(Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119)
- Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119(Days 105 and 119)