Phase III Study of TS-142 in Patients With Insomnia

Study Overview
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Brief Summary
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This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.

Official Title
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A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.

Conditions
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Patients With Insomnia

Intervention / Treatment
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* Drug: TS-142 5 mg
* Drug: TS-142 10 mg
* Drug: Placebo to TS-142


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese male and female who are aged 18 years or older at the time of informed consent Outpatients Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Other protocol defined inclusion criteria could apply. Exclusion Criteria: Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5 Patients with psychiatric disorders such as depression, schizophrenia, and anxiety Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder Other protocol defined exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 mg<br>Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime | Drug: TS-142 5 mg<br>* Participants received repeated doses of 5 mg of TS-142 (oral tablet)<br>|
| Experimental: 10 mg<br>Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime | Drug: TS-142 10 mg<br>* Participants received repeated doses of 10 mg of TS-142 (oral tablet)<br>|
| Placebo Comparator: Placebo<br>Period in which participants received repeated doses of placebo prior to bedtime | Drug: Placebo to TS-142<br>* Participants received repeated doses of placebo to TS-142 (oral tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline | sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary. | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline | sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary. | Baseline and Week 2 | 
| Difference of sTST between TS-142 and placebo in mean change from baseline | sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary. | Baseline and Week 2 | 
| Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline | sWASO is defined as the total amount of time spent awake after falling asleep and before wake-up time as recorded in a sleep diary. | Baseline and Week 2 | 
| Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline | sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary | Baseline and Week 2 |