NCT03267303已完成2 期
A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
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
- 53
- 试验地点
- 1
- 主要终点
- Mean sleep latency in maintenance of wakefulness test
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
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
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
- •Patients aged ≥16 to <65 years at the time of obtaining informed consent
- •Outpatients
排除标准
- •Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
- •Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
- •Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
- •Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)
研究组 & 干预措施
TS-091 5mg
Experimental
干预措施: TS-091 5mg (Drug)
TS-091 10mg
Experimental
干预措施: TS-091 10mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean sleep latency in maintenance of wakefulness test
时间窗: 3 weeks
次要结局
- Total score on the epworth sleepiness scale(3 weeks)
研究者
研究点 (1)
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