NCT05875974

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, multicenter, single-arm, open-label interventional study will assess the safety and efficacy of JZP258 on sleepiness, polysomnography measurements (eg, sleep stage transitions, sleep patterns, and sleep quality), daytime and nighttime symptoms, pharmacokinetics (in narcolepsy), and patient-reported outcomes that include subjective sleep quality and quality of life in patients with IH or narcolepsy.

Conditions

• Idiopathic Hypersomnia
• Narcolepsy

Interventions

Type	Name	Description
DRUG	JZP258 (XYWAV)	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.

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-03-13
• Completion: 2025-03-13
• First posted: 2023-05-25
• Last updated: 2025-07-17

Locations

32 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study