A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
NCT ID: NCT05875974
Last Updated: 2025-07-17
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
207 participants
INTERVENTIONAL
2023-07-27
2025-03-13
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 self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.
JZP258 (XYWAV)
Narcolepsy Cohort: Initiate dosage per XYWAV label and titrate to effect.
IH Cohort: Initiate dosage per XYWAV label and titrate to effect.
Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams.
Interventions
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JZP258 (XYWAV)
Narcolepsy Cohort: Initiate dosage per XYWAV label and titrate to effect.
IH Cohort: Initiate dosage per XYWAV label and titrate to effect.
Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams.
Eligibility Criteria
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Inclusion Criteria
* Has a primary diagnosis of IH meeting International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria or narcolepsy (Type 1 or Type 2) meeting ICSD-3 or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
* If not currently taking oxybate medication, has clinically significant symptoms of Excessive daytime sleepiness (EDS) with an ESS score \> 10 at Screening Visit 1. If currently taking oxybate medication, has an ESS score \> 10 at the Baseline Visit 2 polysomnography (after washout period). Note: Not applicable for participants entering the Narcolepsy \>9-gram cohort (see additional criteria below for the Narcolepsy \>9-gram cohort).
* If currently treated with anticataplectics and/or alerting agents, has been taking the same dosage for at least 1 month prior to Screening Visit 1 and has no current plans to adjust the dosage during the study period. Note: Alerting agents refer to either traditional stimulants (eg, amphetamines, methylphenidates) or wake-promoting agents (eg, modafinil, pitolisant, solriamfetol).
* Is on a current treatment regimen including XYWAV at a dosage of 9 grams
Exclusion Criteria
* Shows evidence of untreated or inadequately treated sleep-disordered breathing during Baseline Visit 2 polysomnography defined as an Apnea/Hypopnea Index (AHI) \> 10, using the US Centers for Medicare and Medicaid Services rules (CMS.gov).
* Has a history or presence of any unstable or clinically significant medical condition (chronic pain condition that may impact sleep), behavioral or psychiatric disorder (including active suicidal ideation or current or past \[within 1 year\] major depressive episode), or history or presence of another neurologic disorder or surgical history that might affect the participant's safety and/or interfere with the conduct of the study, in the opinion of the investigator.
* Has recently taken (ie, within 1 month prior to screening), is taking, or plans to take any of the following:
* A substance or medication contraindicated with XYWAV use, ie. specifically alcohol and sedative hypnotics
* A medication with a known drug-drug interaction with XYWAV
* A medication that may have similar EEG effects to XYWAV
* Medications known to have clinically significant CNS sedative effects
* Other medications, natural health products, or substances from which the participant experiences clinically significant sedation
Additional Exclusion Criterion for Participants in the Narcolepsy \>9-Gram Cohort
• Any past or current medical conditions or experience that, in the investigator's clinical judgment, would preclude further increases in the current oxybate medication dosage beyond 9 grams
18 Years
75 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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JZP258-407
Identifier Type: -
Identifier Source: org_study_id
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