Loading clinical trials...

Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

NCT04573725•Taisho Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

Eligibility

Age

20 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatients
•Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
•Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1

Exclusion Criteria

•Patients with a history of any of the following diseases according to the DSM-5 criteria:
•1. Hypersomnolence disorder
•2. Narcolepsy
•3. Breathing-related sleep disorders
•4. Circadian rhythm sleep-wake disorder
•5. Parasomnias
•6. Restless legs syndrome
•7. Substance/medication-induced sleep disorder
•Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
•Patients with a history of poorly controlled diabetes mellitus (HbA1c \>8%)
+1 more criteria

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Key Dates

Start Date

July 7, 2017

Primary Completion Date

February 13, 2019

Completion Date

February 13, 2019

Last Updated

February 28, 2025

Enrollment

ACTUAL participants

Conditions

Insomnia Disorder

Interventions

TS-142

DRUG

Dose-matched Placebo to TS-142

DRUG

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

NCT05780177

Posttraumatic Stress DisorderInsomnia Disorder

View study

RECRUITINGNA

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

NCT06779149

Insomnia Disorder

View study

COMPLETEDPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

Inclusion Criteria

Exclusion Criteria

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Cultural Adaptation of CBTi for the Arab World

Changed Serum Levels of Sirtuin1 and Sirtuin3 and Their Correlations With Sleep Quality and Cognitive Function in the Patients With Chronic Insomnia Disorder

Digital CBT-I for Insomnia Disorder