Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Placebo | Placebo Comparator | Period in which participants received repeated doses of placebo 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 |
|---|---|---|
| Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline | sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary. | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline | sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary. | Baseline and Week 2 |
| Difference of sTST between TS-142 and placebo in mean change from baseline |
Not provided
Inclusion Criteria:
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Other protocol defined exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 41001841 | Derived | Uchiyama M, Kambe D, Hasegawa S, Imadera Y, Yamasaki H, Uchimura N. Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. Sleep. 2026 Mar 11;49(3):zsaf291. doi: 10.1093/sleep/zsaf291. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000723815 | TS-142 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TS-142 10 mg |
| Drug |
Participants received repeated doses of 10 mg of TS-142 (oral tablet) |
|
| Placebo to TS-142 | Drug | Participants received repeated doses of placebo to TS-142 (oral tablet) |
|
sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary. |
| Baseline and Week 2 |
| Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline | 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. | Baseline and Week 2 |
| Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline | sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary | Baseline and Week 2 |