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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06555783 | A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 | PHASE2 | COMPLETED | 93 | — | — | Jul 26, 2024 | Nov 21, 2025 | Feb 27, 2026 | 47 | United States, Australia +6 |
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
| Arm | Type | Description |
|---|---|---|
| ALKS 2680, 10 mg | EXPERIMENTAL | Oral tablet containing 10mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14 mg | EXPERIMENTAL | Oral tablet containing 14mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18 mg | EXPERIMENTAL | Oral tablet containing 18mg of ALKS 2680 for once daily administration |
| Placebo | PLACEBO_COMPARATOR | Oral tablet containing matching placebo for once daily administration |
| Name | Type | Description |
|---|---|---|
| ALKS 2680 | DRUG | Oral tablet containing ALKS 2680 |
| Placebo | DRUG | Oral tablet containing placebo for once daily administration |
Inclusion Criteria: * 18-70 years of age * Has a BMI ≥18 and ≤40 kg/m2 * Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines. Additionally, meets the following criteria: * Has residual excessive daytime sleepiness * Is willing and able to discontinue any medicatio...