Phase III Study of TS-142 in Patients with Insomnia

Phase 3

Completed

• Conditions: Patients with Insomnia
• Interventions: Drug: Placebo to TS-142; Drug: TS-142 5 mg; Drug: TS-142 10 mg

• Registration Number: NCT05453136
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-08-30
• Status Verified: 2023-09
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1155

Inclusion Criteria

1. Japanese male and female who are aged 18 years or older at the time of informed consent
2. Outpatients
3. 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

1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
2. Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
3. Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder

Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to TS-142	Period in which participants received repeated doses of placebo prior to bedtime
5 mg	TS-142 5 mg	Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime
10 mg	TS-142 10 mg	Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime

Primary Outcome Measures

Name	Time	Method
Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline	Baseline and Week 2	sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.

Secondary Outcome Measures

Name	Time	Method
Difference of sTST between TS-142 and placebo in mean change from baseline	Baseline and Week 2	sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.
Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline	Baseline and Week 2	sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary
Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline	Baseline and Week 2	sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary.
Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline	Baseline and Week 2	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.

Trial Locations

Locations (1)

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