NCT03019419已完成2 期
Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trials
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
- 66
- 试验地点
- 12
- 主要终点
- Change in ALS Functional rating scale
研究概览
简要总结
To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis
详细描述
To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)
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
- 40 Years 至 78 Years（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
Perampanel 4mg
Experimental
Once daily 4mg of perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks
干预措施: Perampanel (Drug)
Perampanel 8mg
Experimental
Once daily 8mg of perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks
干预措施: Perampanel (Drug)
Placebo
Placebo Comparator
Once daily placebo for control for 48 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change in ALS Functional rating scale
时间窗: 48 weeks
次要结局
- Change in ALS Functional rating scale(12, 24, 36, and 48 weeks)
- Manual Muscle Test(12, 24, 36, and 48 weeks)
- Percent-predicted forced vital capacity(12, 24, 36, and 48 weeks)
研究者
研究点 (12)
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