Phase III Study of TS-142 in Patients with Insomnia

JRCT ID: jRCT2031220209

Registered date:09/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: insomnia
• Date of first enrollment: 30/08/2022
• Target sample size: 540
• Study type: Interventional
• Intervention(s): Drug [TS-142(INN:vornorexant) 5 mg, TS-142 10 mg or TS-142 placebo once daily at night prior to bedtime]

Outcome(s)

• Primary Outcome: Subjective sleep latency (sSL) by sleep diary

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Seiji Mita
• Secondary ID(s): NCT05453136