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Completed

NCT Number: NCT04469023

Late Phase II Study of TS-142 in Patients with Insomnia

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

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Key information

Conditions

Patients with Insomnia

Age range

20 year and older

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

  • Japanese male and female age 20 years or older at the time of informed consent
  • Outpatients
  • Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

  • Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
  • Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
  • Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
  • Other protocol defined exclusion criteria could apply

Treatment and study plan

TS-142

Drug

Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)

Primary outcomes

  1. LS mean difference from placebo; Change between baseline and end of the study of sSL

    Time frame: Baseline and Week 2

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

Secondary outcomes

  1. LS mean difference from placebo; Change between baseline and end of the study of sTST

    Time frame: Baseline and Week 2

    sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary

  2. LS mean difference from placebo; Change between baseline and end of the study of sWASO

    Time frame: Baseline and Week 2

    sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 13, 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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