NCT05461352已完成3 期
A Multi-center, Open-label Long-Term 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
- 401
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a randomized, open-label, multi-center long-term 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
- None
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 diseases other than depression and anxiety
- •Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
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)
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)
结局指标
主要结局
Incidence of adverse events
时间窗: From start of investigational drug administration to final test and observation; up to approximately 1 year
To evaluate the Long-term safety of TS-142 in patients with insomnia
次要结局
- Mean change from baseline of subjective sleep latency (sSL)(From baseline up to Week 52)
- Mean change from baseline of subjective total sleep time (sTST)(From baseline up to Week 52)
- Mean change from baseline of subjective sleep efficacy (sSE)(From baseline up to Week 52)
- Mean change from baseline of subjective wake time after sleep onset (sWASO)(From baseline up to Week 52)
- Mean change from baseline of subjective number of awakenings (sNAW)(From baseline up to Week 52)
研究者
研究点 (1)
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