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Completed

NCT Number: NCT05461352

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

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

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

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)

Primary outcomes

  1. Incidence of adverse events

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

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

Secondary outcomes

  1. Mean change from baseline of subjective sleep latency (sSL)

    Time frame: From baseline up to Week 52

    sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary.

  2. Mean change from baseline of subjective sleep efficacy (sSE)

    Time frame: From baseline up to Week 52

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

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

    Time frame: From baseline up to Week 52

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

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

    Time frame: From baseline up to Week 52

    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.

  5. Mean change from baseline of subjective number of awakenings (sNAW)

    Time frame: From baseline up to Week 52

    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, Open-label Long-Term Study of TS-142 in Patients with Insomnia Disorder

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 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.

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