Phase III Study of TS-142 in Patients with Insomnia

Taisho Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Patients with Insomnia

Treatments: Drug: TS-142 10 mg; Drug: TS-142 5 mg; Drug: Placebo to TS-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT05453136

TS142-301

Details and patient eligibility

About

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

Enrollment: 1,155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,155 participants in 3 patient groups, including a placebo group

5 mg

Experimental group

Description:

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

Treatment:

Drug: TS-142 5 mg

10 mg

Experimental group

Description:

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

Treatment:

Drug: TS-142 10 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to TS-142