Late Phase II Study of TS-142 in Patients with Insomnia

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Patients with Insomnia

Treatments: Drug: TS-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT04469023

TS142-203

Details and patient eligibility

About

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

Enrollment: 179 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese male and female age 20 years or older at the time of informed consent
• Outpatients
• Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
• Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
• Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
• 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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179 participants in 4 patient groups

TS-142 2.5 mg

Experimental group

Description:

Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

TS-142 5 mg

Experimental group

Description:

Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

TS-142 10 mg

Experimental group

Description:

Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

Placebo

Experimental group

Description:

Period in which participants received single placebo prior to bedtime

Treatment:

Drug: TS-142