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Sodium Oxybate Formulation

JZP-258 for Narcolepsy

Phase 4
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have been taking Xyrem (with or without additional anticataplectics or stimulants eg, TCA, SNRI, SSRI, atomoxetine) in a stable dose and regimen for at least two months prior to screening, with evidence of clinical improvement on their current regimen, per the investigator's judgement. Only Xyrem will be substituted with XYWAV, with dose and regimen of any concomitant anticataplectics or stimulants remaining unchanged throughout the study.
Sex and Contraceptive/Barrier Requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

Study Summary

This trial is designed to evaluate the safety and efficacy of XYWAV in participants with narcolepsy who are transitioning from treatment with Xyrem.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Weekly Rate of Cataplexy Attacks
Secondary outcome measures
Duration of time between the last meal relative to dosing
Number of Changes from the First Dose and Regimen to Optimized Dose and Regimen
Number of Participants with Participant Global Impression of Change (PGIc) Values
Other outcome measures
Change in Epworth Sleepiness Scale (ESS)
Change in the Nausea Visual Analog Scale (NVAS)
Characterization of Meals Relative to Dosing
+5 more

Side effects data

From 2022 Phase 4 trial • 62 Patients • NCT04794491
3%
COVID-19
3%
Headache
3%
Nasopharyngitis
3%
Diarrhoea
3%
Night sweats
3%
Nausea
2%
Urobilinogen urine increased
2%
Migraine
2%
Paraesthesia
2%
Hot flush
2%
Intentional overdose
2%
Hyperkalaemia
2%
Arthropod bite
2%
Initial insomnia
2%
Haemorrhoids
2%
Suicidal ideation
2%
Chills
2%
Urine abnormality
2%
Sinusitis
2%
Exostosis
2%
Oedema peripheral
2%
Fall
2%
Sedation complication
2%
Somnolence
2%
Conjunctivitis
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label Conversion and Treatment OptimizationExperimental Treatment1 Intervention
Conversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JZP-258
2021
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,297 Total Patients Enrolled
15 Trials studying Narcolepsy
4,022 Patients Enrolled for Narcolepsy

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Michigan
California
Other
Texas
How old are they?
18 - 65
What site did they apply to?
WMed Center for Clinical Research
Stanford University- Sleep Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Stanford University- Sleep Medicine: < 48 hours
Typically responds via
Email
~15 spots leftby Mar 2025