NCT00467441已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with no medical, psychiatric, or current sleep disorders
- •Subject must sign a written consent form
排除标准
- •Evidence of excessive daytime sleepiness
- •History of sleep disorders
- •Psychiatric or neurological disorders
结局指标
主要结局
Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)
次要结局
- Mood
- Psychomotor performance
- Safety and tolerability
研究者
研究点 (1)
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