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

Study Overview
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Brief Summary
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Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

Official Title
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Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Drug: TS-142
* Drug: Dose-matched Placebo to TS-142


Participation Criteria
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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 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: Hypersomnolence disorder Narcolepsy Breathing-related sleep disorders Circadian rhythm sleep-wake disorder Parasomnias Restless legs syndrome 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 mg<br>Period in which participants received single-dose of 5 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)<br>|
| Experimental: 10 mg<br>Period in which participants received single-dose of 10 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)<br>|
| Experimental: 30 mg<br>Period in which participants received single-dose of 30 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)<br>|
| Placebo Comparator: Placebo<br>Period in which participants received single placebo prior to bedtime | Drug: Dose-matched Placebo to TS-142<br>* Participants received single dose-matched placebo to TS-142 (oral capsule)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 |