A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score
研究概览
简要总结
This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease
- •Patients with dyskinesias for at least 3 months
- •Patients with moderate to severe dyskinesias
- •Patients on L-dopa treatment for at least 3 years
排除标准
- •Patients with atypical Parkinson's disease
- •Patients who have had prior surgery for Parkinson's disease
- •Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate
- •Patients who received neuroleptics or anti-psychotics within 2 months
- •Women of child-bearing potential
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
AQW051 High Dose
AQW051 high dose daily given orally for 28 days.
干预措施: AQW051 (Drug)
AQW051 Low Dose
AQW051 low dose daily given orally for 28 days.
干预措施: AQW051 (Drug)
Placebo
Placebo daily given orally for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score
时间窗: Baseline, Day 28
Dyskinesia with a maximal score of 24.
Safety and tolerability
时间窗: Up to Day 42
Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score
时间窗: Baseline, Day 28
Anti-parkinsonian effect in PD patients.
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33(Up to Day 42)
- Track-PD(Up to Day 42)
- CogState(Up to Day 28)
- Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)(Up to Day 42)
- Area under the curve (AUC[0-24hr]) of AQW051(Day 28)