Phase III Study of TS-142 in Patients With Insomnia

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory 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; Drug: Placebo to TS-142

• Study Type: Interventional
• Enrollment (Actual): 1155
• 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

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)
Placebo Comparator: Placebo; Period in which participants received repeated doses of placebo prior to bedtime	Drug: Placebo to TS-142; Participants received repeated doses of placebo to TS-142 (oral tablet)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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): August 30, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: September 1, 2023

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: TS142-301

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