NCT04469023已完成2 期
Late Phase II Study of TS-142 in Patients with Insomnia
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
- 179
- 试验地点
- 1
- 主要终点
- LS mean difference from placebo; Change between baseline and end of the study of sSL
研究概览
简要总结
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male and female age 20 years or older at the time of informed consent
- •Outpatients
- •Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
- •Other protocol defined inclusion criteria could apply
排除标准
- •Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
- •Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
- •Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
TS-142 2.5 mg
Experimental
Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
TS-142 5 mg
Experimental
Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
TS-142 10 mg
Experimental
Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime
干预措施: TS-142 (Drug)
Placebo
Experimental
Period in which participants received single placebo prior to bedtime
干预措施: TS-142 (Drug)
结局指标
主要结局
LS mean difference from placebo; Change between baseline and end of the study of sSL
时间窗: Baseline and Week 2
sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary
次要结局
- LS mean difference from placebo; Change between baseline and end of the study of sWASO(Baseline and Week 2)
- LS mean difference from placebo; Change between baseline and end of the study of sTST(Baseline and Week 2)
研究者
研究点 (1)
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