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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
207
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.
Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-21 weeks)
Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Patient Global Impression of Change (PGI-C) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Time frame: 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)
Time frame: Baseline up to 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)
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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
...and 22 more locations
Time frame: 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
Time frame: 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
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
Time frame: 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