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Phase III Study of TS-142 in Patients With Insomnia

Primary Purpose

Patients With Insomnia

Status

Recruiting

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

TS-142 5 mg

TS-142 10 mg

Placebo to TS-142

About this trial

This is an interventional treatment trial for Patients With Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Japanese male and female who are aged 18 years or older at the time of informed consent
Outpatients
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:

Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
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.

Sites / Locations

Taisho Pharmaceutical Co., Ltd selected siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

5 mg

10 mg

Placebo

Arm Description

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

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

Period in which participants received repeated doses of placebo prior to bedtime

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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

Full Information

NCT ID

NCT05453136

First Posted

July 7, 2022

Last Updated

September 26, 2023

Sponsor

Taisho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05453136

Brief Title

Phase III Study of TS-142 in Patients With Insomnia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 30, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

10 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Period in which participants received repeated doses of placebo prior to bedtime

Intervention Type

Drug

Intervention Name(s)

TS-142 5 mg

Intervention Description

Participants received repeated doses of 5 mg of TS-142 (oral tablet)

Intervention Type

Drug

Intervention Name(s)

TS-142 10 mg

Intervention Description

Participants received repeated doses of 10 mg of TS-142 (oral tablet)

Intervention Type

Drug

Intervention Name(s)

Placebo to TS-142

Intervention Description

Participants received repeated doses of placebo to TS-142 (oral tablet)

Primary Outcome Measure Information:

Title

Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline

Description

sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.

Time Frame

Baseline and Week 2

Secondary Outcome Measure Information:

Title

Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline

Description

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.

Time Frame

Baseline and Week 2

Title

Difference of sTST between TS-142 and placebo in mean change from baseline

Description

sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.

Time Frame

Baseline and Week 2

Title

Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline

Description

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.

Time Frame

Baseline and Week 2

Title

Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline

Description

sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary

Time Frame

Baseline and Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese male and female who are aged 18 years or older at the time of informed consent Outpatients 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: Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5 Patients with psychiatric disorders such as depression, schizophrenia, and anxiety 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taisho Pharmaceutical Co., Ltd.

Phone

81-3-3985-1118

clinical-trials_CTG@taisho.co.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taisho Director

Organizational Affiliation

Taisho Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Taisho Pharmaceutical Co., Ltd selected site

City

Tokyo

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taisho Direcotor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase III Study of TS-142 in Patients With Insomnia

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