Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder

• Status: Completed
• Trial end date: 2019-02-13
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Outpatients

• Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

• Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Patients with a history of any of the following diseases according to the DSM-5 criteria:

1. Hypersomnolence disorder

2. Narcolepsy

3. Breathing-related sleep disorders

4. Circadian rhythm sleep-wake disorder

5. Parasomnias

6. Restless legs syndrome

7. Substance/medication-induced sleep disorder

• Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy

• Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)

• Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder

• Other protocol defined exclusion criteria could apply