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This is a randomized, open-label, multi-center long-term study in patients with insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg | Experimental | Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime |
|
| 10 mg | Experimental | Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 5 mg | Drug | Participants received repeated doses of 5 mg of TS-142 (oral tablet) |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Other protocol defined exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
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| TS-142 10 mg |
| Drug |
Participants received repeated doses of 10 mg of TS-142 (oral tablet) |
|
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 |