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

Phase 2

Completed

• Conditions: Insomnia Disorder

• Registration Number: JPRN-jRCT2080225269
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-09
• Study Completion: 2022-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified