A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 57
- 试验地点
- 37
- 主要终点
- Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15
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 at early stage of the disease.
详细描述
The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 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
- 45 Years 至 80 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
- •Clinical diagnosis of Parkinson's disease.
- •Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
- •Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
- •Able to refrain from any Parkinson's disease medication not permitted by the protocol.
排除标准
- •History or presence of atypical Parkinsonian syndrome.
- •Severe acute or chronic medical or psychiatric condition or cognitive impairment 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
干预措施: Placebo (Drug)
PF-06649751
干预措施: PF-06649751 (Drug)
结局指标
主要结局
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15
时间窗: Baseline (Day -1/randomization), Week 15
MDS-UPDRS Part III was used to assess the motor signs of Parkinson's disease. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The MDS-UPDRS Part III total score range is 0-132. Higher score indicates more severe motor signs of Parkinson's disease. A negative change from baseline represents an improvement in motor function.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose of study treatment up to 28 days after last dose (up to Day 133))
- Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)(Baseline (Day -1/randomization) up to Day 119 follow-up visit)
- Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline (Day -1/randomization) up to Day 119 follow-up visit)
- Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105(Baseline (Day -1 or randomization); Days 35, 63, 105)
- Total Physician Withdrawal Checklist (PWC-20) Score(Day 119)
- Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria(Baseline (Day -1/randomization) up to Day 119 follow-up visit)
- Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters(Baseline (Day -1/randomization) up to Day 119 follow-up visit)