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.

Study Overview

• Status: Completed
• Conditions: Patients With Insomnia
• Intervention / Treatment: Drug: TS-142

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TS-142 2.5 mg; Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime	Drug: TS-142; Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Experimental: TS-142 5 mg; Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime	Drug: TS-142; Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Experimental: TS-142 10 mg; Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime	Drug: TS-142; Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Experimental: Placebo; Period in which participants received single placebo prior to bedtime	Drug: TS-142; Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LS mean difference from placebo; Change between baseline and end of the study of sSL	sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary	Baseline and Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LS mean difference from placebo; Change between baseline and end of the study of sTST	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	Baseline and Week 2
LS mean difference from placebo; Change between baseline and end of the study of sWASO	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.	Baseline and Week 2

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: TS142-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No