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This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg of TS-142 | Experimental | Low dose of TS-142 |
|
| 10 mg of TS-142 | Experimental | High dose of TS-142 |
|
| 7.5 mg of Zopiclone | Experimental | Comparator. |
|
| Placebo | Experimental | Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 | Drug | Single dose of 5 mg of TS-142 |
| |
| TS-142 |
| Measure | Description | Time Frame |
|---|---|---|
| RMS of COP in eye-open condition | the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-open condition | 8 hour postdose |
| Measure | Description | Time Frame |
|---|---|---|
| RMS of COP in eye-closed condition | the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-closed condition | 8 hour postdose |
| Trajectory of COP in eye-open condition |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42174196 | Derived | Miyazaki Y, Kambe D, Imadera Y, Yamasaki H, Uchimura N, Uchiyama M. Comparison of next-morning residual effects by bedtime administration of vornorexant and zopiclone in healthy older participants: postural stability, neuropsychological functions, and subjective sleepiness in a randomized clinical study. Psychopharmacology (Berl). 2026 May 23. doi: 10.1007/s00213-026-07095-8. Online ahead of print. |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
| C515050 | zopiclone |
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| Drug |
Single-dose of 10 mg of TS-142 |
|
| Zopiclone | Drug | Single-dose of 7.5 mg of zopiclone |
|
| Placebo | Drug | Single-dose of placebo |
|
the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition
| 8 hour postdose |
| Trajectory of COP in eye-closed condition | the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition | 8 hour postdose |