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

Phase 2

Completed

• Conditions: Patients with Insomnia
• Interventions: Drug: TS-142

• Registration Number: NCT04469023
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2020-09-09
• Primary Completion: 2021-11-16
• Study Completion: 2021-11-16
• Status Verified: 2021-12
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS-142 2.5 mg	TS-142	Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime
TS-142 5 mg	TS-142	Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime
TS-142 10 mg	TS-142	Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime
Placebo	TS-142	Period in which participants received single placebo prior to bedtime

Primary Outcome Measures

Name	Time	Method
LS mean difference from placebo; Change between baseline and end of the study of sSL	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 Outcome Measures

Name	Time	Method
LS mean difference from placebo; Change between baseline and end of the study of sWASO	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.
LS mean difference from placebo; Change between baseline and end of the study of sTST	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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan