JZP258 for Narcolepsy

Recruiting at 34 trial locations

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jazz Pharmaceuticals

Must be taking: Anticataplectics, Alerting agents

Must not be taking: Alcohol, Sedative hypnotics

Disqualifiers: Sleep-disordered breathing, Major depressive episode, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

207 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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

I feel very sleepy during the day and my sleepiness score is over 10.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer an oral dose of JZP258 (XYWAV) and titrate to an optimal dosage

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XYWAV

Trial Overview 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.

How Is the Trial Designed?

Group I: JZP258 Experimental Treatment 1 Intervention

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

XYWAV is already approved in United States for the following indications:

Approved in United States as XYWAV for:

• Cataplexy or excessive daytime sleepiness in people aged seven years of age and older with narcolepsy
• Idiopathic hypersomnia

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland