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Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg | Experimental | Period in which participants received single-dose of 5 mg TS-142 prior to bedtime |
|
| 10 mg | Experimental | Period in which participants received single-dose of 10 mg TS-142 prior to bedtime |
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| 30 mg | Experimental | Period in which participants received single-dose of 30 mg TS-142 prior to bedtime |
|
| Placebo | Placebo Comparator | Period in which participants received single placebo prior to bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 | Drug | Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule) |
|
| Measure | Description | Time Frame |
|---|---|---|
| LS mean difference of LPS from placebo | LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG. | Day 1 |
| LS mean difference of WASO from placebo | WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| LS mean difference of TST from placebo | TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a history of any of the following diseases according to the DSM-5 criteria:
Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)
Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
Other protocol defined exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Toshiro Heya | 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 |
|---|---|---|---|
| 35296912 | Derived | Uchiyama M, Kambe D, Imadera Y, Kajiyama Y, Ogo H, Uchimura N. Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. Psychopharmacology (Berl). 2022 Jul;239(7):2143-2154. doi: 10.1007/s00213-022-06089-6. Epub 2022 Mar 17. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
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| Dose-matched Placebo to TS-142 | Drug | Participants received single dose-matched placebo to TS-142 (oral capsule) |
|
| D001523 |
| Mental Disorders |