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

Phase 2

Completed

• Conditions: Insomnia Disorder
• Interventions: Drug: TS-142; Drug: Dose-matched Placebo to TS-142

• Registration Number: NCT04573725
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-07
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-29
• Status Verified: 2020-10
• Study First Posted: 2020-10-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
5 mg	TS-142	Period in which participants received single-dose of 5 mg TS-142 prior to bedtime
10 mg	TS-142	Period in which participants received single-dose of 10 mg TS-142 prior to bedtime
Placebo	Dose-matched Placebo to TS-142	Period in which participants received single placebo prior to bedtime
30 mg	TS-142	Period in which participants received single-dose of 30 mg TS-142 prior to bedtime

Primary Outcome Measures

Name	Time	Method
LS mean difference of LPS from placebo	Day 1	LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.
LS mean difference of WASO from placebo	Day 1	WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.

Secondary Outcome Measures

Name	Time	Method
LS mean difference of TST from placebo	Day 1	TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan