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

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Insomnia Disorder

Treatments: Drug: TS-142; Drug: Dose-matched Placebo to TS-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT04573725

TS142-201

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

5 mg

Experimental group

Description:

Period in which participants received single-dose of 5 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

10 mg

Experimental group

Description:

Period in which participants received single-dose of 10 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

30 mg

Experimental group

Description:

Period in which participants received single-dose of 30 mg TS-142 prior to bedtime

Treatment:

Drug: TS-142

Placebo

Placebo Comparator group

Description:

Period in which participants received single placebo prior to bedtime

Treatment:

Drug: Dose-matched Placebo to TS-142