A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcome… (NCT05875974) | Clinical Trial Compass
CompletedPhase 4
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
United States207 participantsStarted 2023-07-27
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Key Inclusion Criteria:
* 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 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).
Additional Inclusion Criteria for Participants in the Narcolepsy \>9-Gram Cohort
* Is on a current treatment regimen including XYWAV at a dosage of 9 grams
Key Exclusion Criteria:
* Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to…
What they're measuring
1
Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV
Timeframe: Baseline up to End of Treatment (approximately 10-36 weeks)