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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Criteria

Inclusion 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

Exclusion Criteria:

• 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