Jazz Pharmaceuticals
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.
Idiopathic Hypersomnia
Narcolepsy
JZP258 (XYWAV)
Phase 4
This prospective, multicenter, single-arm, open-label interventional study will assess the safety and efficacy of JZP258 on sleepiness, polysomnography measurements (eg, sleep stage transitions, sleep patterns, and sleep quality), daytime and nighttime symptoms, pharmacokinetics (in narcolepsy), and patient-reported outcomes that include subjective sleep quality and quality of life in patients with IH or narcolepsy.
Study Type : | Interventional |
Estimated Enrollment : | 186 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 27, 2023 |
Estimated Primary Completion Date : | November 1, 2024 |
Estimated Study Completion Date : | November 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: JZP258 Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant. |
Drug: JZP258 (XYWAV) |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
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Long Beach Research Institute
Lakewood, California, United States, 90805
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Santa Monica Clinical Trials
Los Angeles, California, United States, 90025
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SDS Clinical Trials, Inc.
Santa Ana, California, United States, 92705
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BioSerenity
Altamonte Springs, Florida, United States, 32701
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PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States, 33176
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Florida Hospital for Children
Winter Park, Florida, United States, 32789
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NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30328
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Saltzer Medical Group
Nampa, Idaho, United States, 83686
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Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, United States, 48314
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St. Lukes Hospital Medical Center
Chesterfield, Missouri, United States, 63017
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Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054
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Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina, United States, 28078
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CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
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Intrepid Research
Cincinnati, Ohio, United States, 45245
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Ohio Sleep Medicine and Neuroscience Institute
Dublin, Ohio, United States, 43017
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Abington Neurological Associates, LTD
Abington, Pennsylvania, United States, 19001
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Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States, 29201
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FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
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Comprehensive Sleep Medicine Associates
Houston, Texas, United States, 77030
Recruiting
Sleep Therapy & Research Center
San Antonio, Texas, United States, 78229