A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
研究概览
简要总结
This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
E2007
E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening).
干预措施: Perampanel (Drug)
结局指标
主要结局
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
时间窗: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
次要结局
- Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study(Baseline, Week 0, Week 20, Week 32)
- Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study(Baseline, Week 0, Week 20, Week 32)
- Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study(Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up)