A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
- Conditions
- Idiopathic HypersomniaNarcolepsy
- Interventions
- Drug: JZP258 (XYWAV)
- Registration Number
- NCT05875974
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Is 18 to 75 years of age (inclusive) at the time of signing the informed consent form (ICF)
- 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 who do not washout.
- 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, modafinils, pitolisant, solriamfetol).
Key
-
Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to negatively impact the conduct of the study, including sleep-disordered breathing, parasomnias, circadian rhythm sleep disorders, or restless legs syndrome determined by a previous sleep-laboratory diagnosis or interview utilizing modules of the Diagnostic Interview for Sleep Patterns and Disorders.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JZP258 JZP258 (XYWAV) Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.
- Primary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
- Secondary Outcome Measures
Name Time Method Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks) Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks) Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV Baseline up to End of Treatment (approximately 10-21 weeks) Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks) Pharmacokinetic Parameter Area Under the Concentration-Time Curve From time 0 to Infinity (AUC0-inf) In a Subset of Participants With Narcolepsy Treated With XYWAV PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose Patient Global Impression of Change (PGI-C) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue) End of Treatment (approximately 10-36 weeks) Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue) Baseline up to End of Treatment (approximately 10-36 weeks) Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks) Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary) Baseline up to End of Treatment (approximately 10-36 weeks) Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) In a Subset of Participants With Narcolepsy Treated With XYWAV PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose
Trial Locations
- Locations (32)
Advanced Respiratory and Sleep Medicine, PLLC
🇺🇸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
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
Heritage Medical Research Clinic, University of Calgary
🇨🇦Calgary, Alberta, Canada
AMNDX Inc
🇨🇦Markham, Ontario, Canada
Johda Tishon Inc
🇨🇦Toronto, Ontario, Canada
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Amnova Clinical Research
🇺🇸Irvine, California, United States
TriValley Sleep Center
🇺🇸San Ramon, California, United States
Meris Clinical Research, LLC
🇺🇸Brandon, Florida, 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
Geisinger Clinic
🇺🇸Scranton, Pennsylvania, United States
Tricoastal Narcolepsy and Sleep Disorders Center
🇺🇸Sugar Land, Texas, United States
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Perseverance Research Center, LLC
🇺🇸Scottsdale, Arizona, 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
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, 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
Clinical Neurophysiology Services, P.C.
🇺🇸Sterling Heights, Michigan, United States
St. Lukes Hospital Medical Center
🇺🇸Chesterfield, Missouri, United States