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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 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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV
Secondary outcome measures
Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
+7 more

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
248 Previous Clinical Trials
34,058 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
154 Patients Enrolled for Idiopathic Hypersomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants for this trial required to be of legal age?

"As per the necessary qualifications for this medical trial, individuals need to be aged between 18 and 75."

Answered by AI

How many health care centers are administering this clinical experiment?

"Presently, this trial is conducted in 8 different medical centres. These include Los Angeles, Winter Park and Sterling Heights - as well as 5 other locations. To reduce any associated hardships, it would be wise to select the site nearest you when considering participation."

Answered by AI

Are there any available spots for participation in this research trial?

"Affirmative. According to the research on clinicaltrials.gov, this trial is presently seeking participants since it was first made available on July 27th 2023 and last modified on September 29th 2023. 186 individuals are required between 8 separate sites for the experiment to be successful."

Answered by AI

Has JZP258 received sanctioning from the Food and Drug Administration?

"Our team at Power believe JZP258 is a safe treatment, thus it was assigned an assessment score of 3. This decision was based on the fact that this clinical trial had reached Phase 4 and been approved for use."

Answered by AI

How many individuals are taking part in the research project?

"To fulfill the requirements of this research, 186 individuals that meet pre-established inclusion criteria are needed. Jazz Pharmaceuticals has contracted two medical facilities to carry out the study: Santa Monica Clinical Trials located in Los Angeles and Florida Hospital for Children situated in Winter Park."

Answered by AI

What criteria must an individual fulfill to be accepted into this clinical experiment?

"This clinical trial is searching to enlist 186 adults between 18-75 years of age who have been identified with idiopathic hypersomnia. To be eligible, candidates must meet the following conditions: Male or female aged between 18 and 75 (inclusive) at signing of informed consent form; diagnosis corresponding to ICSD-3 criteria for Idiopathic Hypersomnia or DSM-V standards for narcolepsy type 1/2; ESS score greater than 10 if not taking Xyrem medication, otherwise a minimum ESS score after washout period. For those on alerting agents/anticataplectic drugs,"

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Neurophysiology Services, P.C.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Ph4 PSG Combined JZP258-407
2023. "Ph4 PSG Combined JZP258-407". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05875974.
All > Narcolepsy > Idiopathic Hypersomnia
~74 spots leftby Nov 2024
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