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JZP258 for Narcolepsy

Phase 4
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if a new drug can help reduce sleepiness in people with narcolepsy or idiopathic hypersomnia.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While the side effects are not explicitly listed here, similar medications often cause dizziness, headache, nausea, insomnia, decreased appetite and potential risk of abuse or dependence due to its central nervous system activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
250 Previous Clinical Trials
34,767 Total Patients Enrolled
1 Trials studying Excessive Daytime Sleepiness
59 Patients Enrolled for Excessive Daytime Sleepiness
~44 spots leftby Mar 2025
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