Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00291187 | VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia | PHASE3 | COMPLETED | 411 | — | — | Feb 1, 2006 | Aug 1, 2006 | Oct 15, 2014 | 19 | United States |
The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Take orally 30 minutes prior to bedtime. |
| 20 mg VEC-162 | EXPERIMENTAL | 20 mg taken orally 30 minutes prior to bedtime. |
| 50 mg VEC-162 | EXPERIMENTAL | 50 mg taken orally 30 minutes prior to bedtime. |
| 100 mg VEC-162 | EXPERIMENTAL | 100 mg taken orally 30 minutes prior to bedtime. |
| Name | Type | Description |
|---|---|---|
| 20 mg VEC-162 | DRUG | 20 mg VEC-162 |
| 50 mg VEC-162 | DRUG | 50 mg VEC-162 |
| 100 mg VEC-162 | DRUG | 100 mg VEC-162 |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Healthy subjects with no medical, psychiatric or current sleep disorders. * Subject must sign a written consent form. Exclusion Criteria: * Recent history of night shift work or jet lag. * Prior experience sleeping in a sleep lab environment. * History of sleep disorders.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Unity Health Toronto | UBX | 1 | PHASE2 | Lemborexant |
| ResMed Inc. | RMD | 1 | NA | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | — | Daridorexant, Non-orexin receptor antagonist medications for insomnia |