Status:
COMPLETED
Late Phase II Study of TS-142 in Patients with Insomnia
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Patients with Insomnia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2021
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04469023
Start Date
September 9 2020
End Date
November 16 2021
Last Update
February 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan