Long-Term Study of TS-142 in Patients With Insomnia

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, multi-center long-term study in patients with insomnia.

Official Title
-----------------
A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder

Conditions
-----------------
Patients With Insomnia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 diseases other than depression and anxiety Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep Other protocol defined exclusion criteria could apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | To evaluate the Long-term safety of TS-142 in patients with insomnia | From start of investigational drug administration to final test and observation; up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline of subjective sleep latency (sSL) | sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary. | From baseline up to Week 52 | 
| Mean change from baseline of subjective sleep efficacy (sSE) | sSE is defined as the percentage of total sleep time (TST) in total amount of time from bedtime to wake-up time in a sleep diary. | From baseline up to Week 52 | 
| Mean change from baseline of subjective total sleep time (sTST) | sTST defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary. | From baseline up to Week 52 | 
| Mean change from baseline of subjective wake time after sleep onset (sWASO) | 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. | From baseline up to Week 52 | 
| Mean change from baseline of subjective number of awakenings (sNAW) | sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary | From baseline up to Week 52 |