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

Phase 2CompletedNCT04573725

Taisho Pharmaceutical Co., Ltd.24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Insomnia Disorder

Interventions

TS-142DRUG

Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)

Dose-matched Placebo to TS-142DRUG

Participants received single dose-matched placebo to TS-142 (oral capsule)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Outcomes

Primary Outcomes

LS mean difference of LPS from placebo

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.

Time frame: Day 1

LS mean difference of WASO from placebo

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.

Time frame: Day 1

Secondary Outcomes

LS mean difference of TST from placebo

TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.

Time frame: Day 1

Data from ClinicalTrials.gov

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