Phase III Study of TS-142 in Patients with Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-12-05

Brief Summary

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

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Detailed Description

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Conditions

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Patients with Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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5 mg

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

Group Type EXPERIMENTAL

TS-142 5 mg

Intervention Type DRUG

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

10 mg

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

Group Type EXPERIMENTAL

TS-142 10 mg

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo to TS-142

Intervention Type DRUG

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

Interventions

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TS-142 5 mg

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

Intervention Type DRUG

TS-142 10 mg

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

Intervention Type DRUG

Placebo to TS-142

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

Intervention Type DRUG

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No