NCT05453136已完成3 期
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,155
- 试验地点
- 1
- 主要终点
- Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline
研究概览
简要总结
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male and female who are aged 18 years or older at the time of informed consent
- •Outpatients
- •Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
- •Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
- •Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
10 mg
Experimental
Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime
干预措施: TS-142 10 mg (Drug)
5 mg
Experimental
Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime
干预措施: TS-142 5 mg (Drug)
Placebo
Placebo Comparator
Period in which participants received repeated doses of placebo prior to bedtime
干预措施: Placebo to TS-142 (Drug)
结局指标
主要结局
Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline
时间窗: Baseline and Week 2
sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.
次要结局
- Difference of sTST between TS-142 and placebo in mean change from baseline(Baseline and Week 2)
- Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline(Baseline and Week 2)
- Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline(Baseline and Week 2)
- Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline(Baseline and Week 2)
研究者
研究点 (1)
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