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

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

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

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