At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 207 enrolled
Drug / intervention
JZP258 (XYWAV)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy
In Brief
A Phase 4 clinical trial evaluating JZP258 (XYWAV) for Idiopathic Hypersomnia and Narcolepsy. Completed, enrolled 207 participants across 32 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Hypersomnia, Narcolepsy
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
202420252026
First PostedMay 2023
Enrollment StartJul 2023
Primary CompletionMar 2025
TodayJul 2026
First PostedMay 25, 2023
Enrollment StartJul 27, 2023
Primary CompletionMar 13, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.1 years ago
Interventions
JZP258 (XYWAV)drug
Narcolepsy Cohort: Initiate dosage per XYWAV label and titrate to effect. IH Cohort: Initiate dosage per XYWAV label and titrate to effect. Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams.