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A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Sponsor: Jazz Pharmaceuticals
Summary
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
Official title: A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
199
Start Date
2023-07-27
Completion Date
2025-03-13
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
JZP258 (XYWAV)
Narcolepsy Cohort: Initiate dosage per XYWAV label and titrate to effect. IH Cohort: Initiate dosage per XYWAV label and titrate to effect. Exploratory Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams.
Locations (32)
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Amnova Clinical Research
Irvine, California, United States
Long Beach Research Institute
Lakewood, California, United States
Santa Monica Clinical Trials
Los Angeles, 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
Meris Clinical Research, LLC
Brandon, Florida, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States
Florida Hospital for Children
Winter Park, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research
Rincon, Georgia, United States
Neurocare, Inc., dba Neurocare Center for Research
Newtown, Massachusetts, United States
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, United States
St. Lukes Hospital Medical Center
Chesterfield, Missouri, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Stern Research Partners, LLC
Huntersville, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus - Clinical Research Unit
Cleveland, Ohio, United States
Ohio Sleep Medicine and Neuroscience Institute
Dublin, Ohio, United States
Abington Neurological Associates, LTD
Abington, Pennsylvania, United States
Geisinger Clinic
Scranton, Pennsylvania, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Comprehensive Sleep Medicine Associates
Houston, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Tricoastal Narcolepsy and Sleep Disorders Center
Sugar Land, Texas, United States
Heritage Medical Research Clinic, University of Calgary
Calgary, Alberta, Canada
AMNDX Inc
Markham, Ontario, Canada
Johda Tishon Inc
Toronto, Ontario, Canada