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

A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder

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

Study Overview

• Status: Completed
• Conditions: Patients With Insomnia
• Intervention / Treatment: Drug: TS-142 5 mg; Drug: TS-142 10 mg

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Taisho Pharmaceutical Co., Ltd.; Phone Number: +81-3-3985-1118; Email: clinical-trials_CTG@taisho.co.jp

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg; Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime	Drug: TS-142 5 mg; Participants received repeated doses of 5 mg of TS-142 (oral tablet)
Experimental: 10 mg; Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime	Drug: TS-142 10 mg; Participants received repeated doses of 10 mg of TS-142 (oral tablet)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): March 7, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

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: TS142-302

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