A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
NCT ID: NCT05869773
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2023-06-26
2025-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JZP258
Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.
JZP258
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Interventions
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JZP258
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
* Participants must have been receiving a total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6 consecutive weeks prior to screening.
* If currently treated with stimulants and/or alerting agents or other medications known to affect BP, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study.
* If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care
* Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective.
Exclusion Criteria
* Presence of significant cardiovascular disease or cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study, including screening ECG results.
* Presence of atrial fibrillation detected on screening electrocardiogram (ECG).
* Presence of resistant hypertension.
18 Years
70 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Science 37
Culver City, California, United States
M3 Wake Research
Encino, California, United States
So Cal Clinical Research
Huntington Beach, California, United States
Long Beach Research Institute
Lakewood, California, United States
Stanford School of Medicine
Redwood City, California, United States
TriValley Sleep Center
San Ramon, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
FWD Clinical Research
Boca Raton, Florida, United States
Meris Clinical Research, LLC
Brandon, Florida, United States
Ocean Wellness Center
Miami, Florida, United States
Serenity Research Center LLC
Miami, Florida, United States
Florida Pediatric Research Institute, LLC
Orlando, Florida, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
Saltzer Medical Group
Nampa, Idaho, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Neurocare, Inc
Newton, Massachusetts, United States
Sparrow Health System
Lansing, Michigan, United States
Bryan Medical Center
Lincoln, Nebraska, United States
Henderson Clinical Trials LLC
Henderson, Nevada, United States
Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina, United States
Intrepid Research, LLC
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio Sleep Medicine and Neuroscience
Dublin, Ohio, United States
OHSU Hospital
Portland, Oregon, United States
Abington Neurological Associates, LTD
Abington, Pennsylvania, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Velocity Clinical Research, Greenville
Greenville, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Antwerp University Hospital (UZA)
Edegem, , Belgium
Private Practice RESPISOM Namur
Namur, , Belgium
Hopital Gui de Chauliac
Montpellier, Herault, France
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, France
CHU Nantes - Hôtel Dieu
Nantes, Loire Atlantique, France
IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
Bologna, , Italy
Ospedale San Raffaele (San Raffaele Turro)
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, , Italy
Hospital Universitario Araba - Sede Santiago
Vitoria-Gasteiz, Alava, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General de Castellon
Castellon, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Countries
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References
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White WB, Kovacs RJ, Alexander JK, Baranak C, Nichols DA, Fuller DS, Dai J, Whalen M, Ajayi A, Hutchinson B, Dauvilliers Y, Somers VK. Effects of High- Versus Low-Sodium Oxybate on Blood Pressure in Patients With Narcolepsy. Hypertension. 2025 Oct 15. doi: 10.1161/HYPERTENSIONAHA.125.25730. Online ahead of print.
Other Identifiers
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JZP258-406
Identifier Type: -
Identifier Source: org_study_id
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