Phase III Study of TS-142 in Patients with Insomnia
- Conditions
- insomnia
- Registration Number
- JPRN-jRCT2031220209
- Lead Sponsor
- Seiji Mita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
1. Japanese male and female who are aged 18 years or older at the time of informed consent
2. Outpatients
3. 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.
1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
2. Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
3. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method