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Phase III Study of TS-142 in Patients with Insomnia

NCT05453136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1155

Last updated 2025-02-28

No results posted yet for this study

Summary

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

Conditions

  • Patients with Insomnia

Interventions

DRUG

TS-142 5 mg

Participants received repeated doses of 5 mg of TS-142 (oral tablet)

DRUG

TS-142 10 mg

Participants received repeated doses of 10 mg of TS-142 (oral tablet)

DRUG

Placebo to TS-142

Participants received repeated doses of placebo to TS-142 (oral tablet)

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taisho Director · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-12-05
Completion
2023-12-05

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 NCT05453136 on ClinicalTrials.gov