Skip to main content
OpenTrials
Completed

NCT Number: NCT05453136

Phase III Study of TS-142 in Patients with Insomnia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patients with Insomnia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Other protocol defined inclusion criteria could apply.

Exclusion criteria

  • 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

Other protocol defined exclusion criteria could apply.

Treatment and study plan

TS-142 5 mg

Drug

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

TS-142 10 mg

Drug

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

Placebo to TS-142

Drug

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

Primary outcomes

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

    Time frame: Baseline and Week 2

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

Secondary outcomes

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

    Time frame: Baseline and Week 2

    sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary.

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

    Time frame: Baseline and Week 2

    sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.

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

    Time frame: Baseline and Week 2

    sWASO is defined as the total amount of time spent awake after falling asleep and before wake-up time as recorded in a sleep diary.

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

    Time frame: Baseline and Week 2

    sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.