A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
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Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
155actual
Sites
43
Countries
Belgium, France, Italy +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-26 | actual | When the study began enrolling |
| Primary completion | 2025-02-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-10 | actual | The whole study's end, after follow-up |
| First posted | 2023-05-22 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-24 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Narcolepsy
Intervention
- Drug: JZP258 — also filed as Xywav
Primary outcome
what the primary-completion date above is the date OFChange From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg
measured Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-05-17 · 905 KB · Prot_000.pdf
Statistical Analysis Planposted 2024-12-05 · 979 KB · SAP_001.pdf
Publications
- PMID 41090230 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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