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NCT04794491 · ClinicalTrials.gov registry record · Phase 4
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
A Phase 4 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT04794491: Completed Phase 4 study, sponsored by Jazz Pharmaceuticals.
NCT04794491 is a Phase 4 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04794491, a Phase 4 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
Primary Outcome
Mean weekly rate of cataplexy attack = (total number of cataplexy attacks reported during the period/number of days during the period where a diary was completed) x 7.
Interventions
- DRUG JZP-258
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 4 |
What the finished NCT04794491 record still lists
NCT04794491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which JZP-258 is the first listed.
NCT04794491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04794491 about?
NCT04794491 is a clinical study titled "An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy". The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
What is the current status of trial NCT04794491?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2021-03-22. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04794491?
The interventions under investigation include: JZP-258 (DRUG).
Who is sponsoring clinical trial NCT04794491?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04794491's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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