Trials / Completed
CompletedNCT05869773
A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JZP258 | 0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2025-02-25
- Completion
- 2025-03-10
- First posted
- 2023-05-22
- Last updated
- 2025-04-08
Locations
43 sites across 5 countries: United States, Belgium, France, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05869773. Inclusion in this directory is not an endorsement.