An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Public ClinicalTrials.gov record NCT04794491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04794491
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 22, 2021 (Actual)
- Primary completion
- Nov 15, 2022 (Actual)
- Completion
- Nov 15, 2022 (Actual)
- Last update posted
- Jan 9, 2024
2021 – 2022
United States locations
- U.S. sites
- 28
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wright Clinical Research, LLC | Alabaster | Alabama | 35007 | — |
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| Pulmonary Associates of the Southeast, PC | Birmingham | Alabama | 35254 | — |
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | — |
| Southern California Institute For Respiratory Diseases, Inc./ Tower Sleep Medicine | Los Angeles | California | 90048 | — |
| Southern California Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | — |
| Stanford University- Sleep Medicine | Redwood City | California | 94063 | — |
| SDS Clinical Trials, Inc | Santa Ana | California | 92705 | — |
| Delta Waves, Inc. | Colorado Springs | Colorado | 80918 | — |
| Pulmonary Disease Specialists, PA d/b/a PDS Research | Kissimmee | Florida | 34741 | — |
| Clinical Research of West Florida, Inc | Tampa | Florida | 33606 | — |
| Florida Pediatric Research Institute, LLC | Winter Park | Florida | 32789 | — |
| Sleep Practitioners LLC | Macon | Georgia | 31210 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| WMed Center for Clinical Research | Kalamazoo | Michigan | 49008 | — |
| Minnesota Lung Center | Edina | Minnesota | 55435 | — |
| Clayton Sleep Institute, LLC | St Louis | Missouri | 63123 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Intrepid Research LLC | Cincinnati | Ohio | 45245 | — |
| Cleveland Clinic, Sleep Disorders Center | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences | North Charleston | South Carolina | 29425 | — |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04794491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 9, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04794491 live on ClinicalTrials.gov.