Long-Term Study of TS-142 in Patients with Insomnia

Phase 3

Completed

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

• Registration Number: NCT05461352
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

This is a randomized, open-label, multi-center long-term study in patients with insomnia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Study Start: 2022-10-11
• Status Verified: 2024-03
• Primary Completion: 2024-03-07
• Study Completion: 2024-03-07
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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 diseases other than depression and anxiety
3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep

Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	From start of investigational drug administration to final test and observation; up to approximately 1 year	To evaluate the Long-term safety of TS-142 in patients with insomnia

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline of subjective sleep latency (sSL)	From baseline up to Week 52	sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary.
Mean change from baseline of subjective total sleep time (sTST)	From baseline up to Week 52	sTST defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.
Mean change from baseline of subjective sleep efficacy (sSE)	From baseline up to Week 52	sSE is defined as the percentage of total sleep time (TST) in total amount of time from bedtime to wake-up time in a sleep diary.
Mean change from baseline of subjective wake time after sleep onset (sWASO)	From baseline up to Week 52	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.
Mean change from baseline of subjective number of awakenings (sNAW)	From baseline up to Week 52	sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary

Trial Locations

Locations (1)

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