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

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

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

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