Late Phase II 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 exploratory study in patients with insomnia.

Official Title
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Late Phase II Study of TS-142 in Patients With Insomnia

Conditions
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Patients With Insomnia

Intervention / Treatment
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* Drug: TS-142


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese male and female age 20 years or older at the time of informed consent Outpatients Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder Other protocol defined inclusion criteria could apply Exclusion Criteria: Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1 Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1 Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 20 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: TS-142 2.5 mg<br>Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)<br>|
| Experimental: TS-142 5 mg<br>Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)<br>|
| Experimental: TS-142 10 mg<br>Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime | Drug: TS-142<br>* Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)<br>|
| Experimental: Placebo<br>Period in which participants received single placebo prior to bedtime | Drug: TS-142<br>* Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LS mean difference from placebo; Change between baseline and end of the study of sSL | sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LS mean difference from placebo; Change between baseline and end of the study of sTST | sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary | Baseline and Week 2 | 
| LS mean difference from placebo; Change between baseline and end of the study of sWASO | sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary. | Baseline and Week 2 |