Trials / Completed
CompletedNCT04794491
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of Narcolepsy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JZP-258 | Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose \> 6 g |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2022-11-15
- Completion
- 2022-11-15
- First posted
- 2021-03-12
- Last updated
- 2024-01-09
- Results posted
- 2024-01-09
Locations
28 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04794491. Inclusion in this directory is not an endorsement.