JZP258 for Narcolepsy

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Jazz Pharmaceuticals

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults aged 18-75 with idiopathic hypersomnia or narcolepsy, who meet specific diagnostic criteria. Participants should be on a stable dose of anticataplectics/alerting agents for at least one month if applicable, and not planning to change dosages during the study. Those not on oxybate must have significant daytime sleepiness (ESS score >10). Exclusions include unstable medical conditions, certain psychiatric disorders, other untreated sleep disorders, or use of sedating medications.

Inclusion Criteria

I've been on a stable dose of medication for sleepiness or cataplexy for at least 1 month.

I am between 18 and 75 years old.

I have been diagnosed with IH or narcolepsy according to recognized standards.

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Exclusion Criteria

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

My sleep study shows I have moderate to severe sleep apnea.

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

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Treatment Details

Interventions

XYWAV (Other)

Trial OverviewThe trial is testing JZP258 (XYWAV) to see how safe and effective it is in reducing excessive daytime sleepiness and improving overall function in patients with idiopathic hypersomnia or narcolepsy. The study will monitor participants' sleep patterns using polysomnography and assess their functional outcomes.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: JZP258Experimental Treatment1 Intervention

Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.