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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07625280 | A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH | PHASE3 | NOT YET_RECRUITING | 108 | — | — | Jun 30, 2026 | Jan 6, 2028 | Jun 4, 2026 | 1 | United States |
ESS is a self-administered questionnaire with 8 questions. Each question is scored on a scale ranging from 0 (would never fall asleep) to 3 (high chance of falling asleep). It has a total score ranging from 0 to 24, with a higher score representing increased daytime sleepiness.
| Arm | Type | Description |
|---|---|---|
| Once-nightly stable dose Xywav group | ACTIVE_COMPARATOR | Participants assigned to cohort 1 will receive once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| Once-nightly placebo group | PLACEBO_COMPARATOR | Participants assigned to cohort 1 will receive once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| Twice nightly stable dose Xywav group | ACTIVE_COMPARATOR | Participants assigned to cohort 2 will receive twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks. |
| Twice nightly placebo group | PLACEBO_COMPARATOR | Participants assigned to cohort 2 will receive twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks. |
| Name | Type | Description |
|---|---|---|
| Xywav | DRUG | 0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth |
| Placebo | OTHER | Placebo solution taken by mouth |
Inclusion Criteria: 1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2) 2. If not currently treated with oxybate, has clinically significant symptoms of excessive daytime sleepiness (EDS) with an Epworth Sleepiness Scale (ESS) score \> 11 at screening. 3. If currently treat...