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A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Sponsor: Jazz Pharmaceuticals
Summary
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.
Official title: An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to Xywav
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2023-06-26
Completion Date
2025-03-10
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
JZP258
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Locations (43)
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