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Completed

NCT Number: NCT04573725

Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

  • Outpatients
  • Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

  • Patients with a history of any of the following diseases according to the DSM-5 criteria:
  • Hypersomnolence disorder
  • Narcolepsy
  • Breathing-related sleep disorders
  • Circadian rhythm sleep-wake disorder
  • Parasomnias
  • Restless legs syndrome
  • Substance/medication-induced sleep disorder
  • Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
  • Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)
  • Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
  • Other protocol defined exclusion criteria could apply

Treatment and study plan

TS-142

Drug

Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)

Dose-matched Placebo to TS-142

Drug

Participants received single dose-matched placebo to TS-142 (oral capsule)

Primary outcomes

  1. LS mean difference of LPS from placebo

    Time frame: Day 1

    LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.

  2. LS mean difference of WASO from placebo

    Time frame: Day 1

    WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.

Secondary outcomes

  1. LS mean difference of TST from placebo

    Time frame: Day 1

    TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2020
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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