Long-Term Study of TS-142 in Patients with Insomnia

NCT05461352 | Completed Phase 3

• 1 other identifier: TS142-302
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, multi-center long-term study in patients with insomnia.

Conditions

Patients with Insomnia

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  To evaluate the Long-term safety of TS-142 in patients with insomnia

  From start of investigational drug administration to final test and observation; up to approximately 1 year

Secondary Outcomes (5)

• Mean change from baseline of subjective sleep latency (sSL)

  From baseline up to Week 52

• Mean change from baseline of subjective sleep efficacy (sSE)

  From baseline up to Week 52

• Mean change from baseline of subjective total sleep time (sTST)

  From baseline up to Week 52

• Mean change from baseline of subjective wake time after sleep onset (sWASO)

  From baseline up to Week 52

• Mean change from baseline of subjective number of awakenings (sNAW)

  From baseline up to Week 52

Study Arms (2)

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

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

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 diseases other than depression and anxiety
• Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 18, 2022
• Study Start: October 11, 2022
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: February 28, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)