Jazz Pharmaceuticals: Narcolepsy trials

The registry lists 18 Narcolepsy studies with Jazz Pharmaceuticals as lead sponsor. 1 are open to participants now and 12 have results posted.

Phase 1 1Phase 2 3Phase 3 8Phase 4 3No phase 3(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IHRecruitingNCT07625280Phase 3
• A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or NarcolepsyCompletedNCT05875974Phase 4Results posted
• A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With NarcolepsyCompletedNCT05869773Phase 4Results posted
• An Interventional Safety Switch Study (Segue Study) of XYWAV in NarcolepsyCompletedNCT04794491Phase 4Results posted
• A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With CataplexyCompletedNCT03030599Phase 3Results posted
• Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in NarcolepsyCompletedNCT02806908Phase 2Results posted
• "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"CompletedNCT02348632Phase 3Results posted
• "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"CompletedNCT02348593Phase 3Results posted
• A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With CataplexyCompletedNCT02221869Phase 3Results posted
• A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With NarcolepsyCompletedNCT01681121Phase 2Results posted
• A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime SleepinessCompletedNCT01485770Phase 2Results posted
• Trial of Xyrem® (Sodium Oxybate) for the Treatment of NarcolepsyCompletedNCT00132873Phase 3Results posted
• Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in NarcolepsyCompletedNCT00066170Phase 3Results posted
• A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1TerminatedNCT06961266Phase 1
• Child and Adolescent Registry for Participants With NarcolepsyStatus unknownNCT04899947
• A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in NarcolepsyCompletedNCT04803786
• A Web-based Observational Study of Patient-reported Outcomes in Adults With NarcolepsyCompletedNCT02769780
• Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic PatientsCompletedNCT00049803Phase 3