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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-07

Study Completion Date

2019-02-13

Brief Summary

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

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Detailed Description

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Conditions

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Insomnia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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5 mg

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

Group Type EXPERIMENTAL

TS-142

Intervention Type DRUG

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

10 mg

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

Group Type EXPERIMENTAL

TS-142

Intervention Type DRUG

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

30 mg

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

Group Type EXPERIMENTAL

TS-142

Intervention Type DRUG

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

Placebo

Period in which participants received single placebo prior to bedtime

Group Type PLACEBO_COMPARATOR

Dose-matched Placebo to TS-142

Intervention Type DRUG

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

Interventions

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TS-142

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

Intervention Type DRUG

Dose-matched Placebo to TS-142

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No