jRCT2080225269已完成2 期
Late Phase II Study of TS-142 in Patients with Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel-group Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit(—)
- 性别
- All
入选标准
- •To be eligible for study participation, an individual must meet all of the following criteria:
- •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
- •An individual who meets any of the following criteria will be excluded from participation
- •in this study:
- •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
结局指标
主要结局
-
efficacy Sujective sleep latency (sSL)
次要结局
未报告次要终点
研究者
研究点 (1)
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