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

JRCT ID: jRCT2031220208

Registered date:08/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 11/10/2022
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Drug [TS-142(INN:vornorexant) 5 mg or TS-142 10 mg once a day at night prior to bedtime]

Outcome(s)

• Primary Outcome: Adverse Event

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Seiji Mita
• Secondary ID(s): NCT05461352