A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose "Wearing-Off" Motor Fluctuations
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Eisai Inc.
- 入组人数
- 25
- 试验地点
- 9
- 主要终点
- Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
研究概览
简要总结
Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 [Visit 2] through Week 12 [Visit 7]) followed by the Maintenance Phase (from Week 12 [Visit 7] to end of study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
1
干预措施: E2007 (Drug)
结局指标
主要结局
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
时间窗: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
次要结局
- Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study(Baseline, Week 12, Week 20, Week 32, Week 44, Week 56)
- Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study(Baseline, Week 12, Week 20, Week 32, Week 44, Week 56)
- Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study(Baseline, Week 12, Week 20, Week 32, Week 44, Week 56)