NCT01385592已完成2 期
12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile
研究概览
简要总结
This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
- •Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks
排除标准
- •Surgical treatment for PD
- •Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
- •Advanced, severe or unstable disease (other than PD) or evidence of dementia that may interfere with the study outcome evaluations
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AFQ056 100 mg
Experimental
干预措施: AFQ056 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile
时间窗: 12 weeks
次要结局
- Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)(12 weeks)
- Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)(12 weeks)
- Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )(12 weeks)
- Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)(12 weeks)
- Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events(12 weeks)
研究者
研究点 (1)
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