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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07540897 | A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) | PHASE3 | RECRUITING | 150 | — | — | May 1, 2026 | Jul 1, 2027 | May 27, 2026 | 1 | United States |
| NCT07455383 | A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | PHASE3 | RECRUITING | 150 | — | — | Apr 6, 2026 | Jun 1, 2027 | Jun 4, 2026 | 17 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| ALKS 2680 Dose 1 | EXPERIMENTAL | - |
| ALKS 2680 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALKS 2680 Dose 1 | DRUG | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
| ALKS 2680 Dose 2 | DRUG | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
| Placebo | DRUG | Participants will receive placebo tablets, daily, orally for 12 weeks |
Inclusion Criteria: * Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level) Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a h...