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

NCT04573725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-28

No results posted yet for this study

Summary

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

Conditions

  • Insomnia Disorder

Interventions

DRUG

TS-142

Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)

DRUG

Dose-matched Placebo to TS-142

Participants received single dose-matched placebo to TS-142 (oral capsule)

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Toshiro Heya · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2019-02-13
Completion
2019-02-13

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573725 on ClinicalTrials.gov