Long-Term Study of TS-142 in Patients with Insomnia

Taisho Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Patients with Insomnia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05461352

TS142-302

Details and patient eligibility

About

This is a randomized, open-label, multi-center long-term study in patients with insomnia.

Enrollment: 401 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 diseases other than depression and anxiety
3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep

Other protocol defined exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups

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