Phase III Study of TS-142 in Patients with Insomnia

NCT05453136 | Completed Phase 3

• 1 other identifier: TS142-301
• Study Type: interventional
• Target: 1,155
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients with Insomnia

Outcome Measures

Primary Outcomes (1)

• Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline

  sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.

  Baseline and Week 2

Secondary Outcomes (4)

• Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline

  Baseline and Week 2

• Difference of sTST between TS-142 and placebo in mean change from baseline

  Baseline and Week 2

• Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline

  Baseline and Week 2

• Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline

  Baseline and Week 2

Study Arms (3)

5 mg

EXPERIMENTAL

Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime

Drug: TS-142 5 mg

10 mg

EXPERIMENTAL

Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime

Drug: TS-142 10 mg

Placebo

PLACEBO COMPARATOR

Period in which participants received repeated doses of placebo prior to bedtime

Drug: Placebo to TS-142

Interventions

TS-142 5 mg DRUG

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

5 mg

TS-142 10 mg DRUG

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

10 mg

Placebo to TS-142 DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese male and female who are aged 18 years or older at the time of informed consent
• Outpatients
• Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)

You may not qualify if:

• Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
• Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
• Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (\> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: August 30, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: February 28, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)