drugset / Trial / NCT05875974
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
NaSingle-groupOpen-labelTreatment
Summary
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
Timeline
- Start
- 2023-07-27
- Primary completion
- 2025-03-13
- Completion
- 2025-03-13
Publications
- Schneider LD, Ruoff CM, Plante DT, Nichols DA, Steininger TL, Fuller DS, Kirby MT, Akerman S, Alexander JK, Whalen M, Cairns A. Effectiveness and Safety of Low-Sodium Oxybate in Participants with Narcolepsy: Primary Results from the DUET Study. Neurol Ther. 2026 Apr 30. doi: 10.1007/s40120-026-00921-3. Online ahead of print.
- Plante DT, Cairns A, Schneider LD, Nichols DA, Steininger TL, Fuller DS, Kirby MT, Akerman S, Alexander JK, Whalen M, Ruoff CM. Effectiveness and Safety of Low-Sodium Oxybate in Participants with Idiopathic Hypersomnia: Primary Results from the DUET Study. CNS Drugs. 2026 Jun;40(6):803-822. doi: 10.1007/s40263-025-01262-9. Epub 2026 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Oxybate | Unknown | 12 g | Oral |