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临床试验/jRCT2080225269
jRCT2080225269已完成2 期

Late Phase II Study of TS-142 in Patients with Insomnia

Taisho Pharmaceutical Co., Ltd.1 个研究点目标入组 160 人开始时间: 待定最近更新:

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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