JZP-258 for Narcolepsy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Narcolepsy
JZP-258 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 8

Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
Change in Weekly Rate of Cataplexy Attacks
Change in the Nausea Visual Analog Scale (NVAS)
Characterization of Meals Relative to Dosing
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 Converted from Xyrem to XYWAV
Number of Participants Dosing Fasted Versus Dosing Without Consideration of Food
Time to Achieve Optimized Dose and Regimen
Week 8
Number of Participants with Participant Global Impression of Change (PGIc) Values

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

JZP-258
22%Headache
13%Nausea
11%Dizziness
10%Cataplexy
9%Nasopharyngitis
8%Influenza
7%Decreased appetite
6%Diarrhoea
5%Upper respiratory tract infection
2%Somnolence
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03030599) in the JZP-258 ARM group. Side effects include: Headache with 22%, Nausea with 13%, Dizziness with 11%, Cataplexy with 10%, Nasopharyngitis with 9%.

Trial Design

1 Treatment Group

Open-Label Conversion and Treatment Optimization
1 of 1

Experimental Treatment

62 Total Participants · 1 Treatment Group

Primary Treatment: JZP-258 · No Placebo Group · Phase 4

Open-Label Conversion and Treatment Optimization
Drug
Experimental Group · 1 Intervention: JZP-258 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gamma-Hydroxybutyric acid
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 8

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
212 Previous Clinical Trials
29,696 Total Patients Enrolled
13 Trials studying Narcolepsy
3,747 Patients Enrolled for Narcolepsy

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas25.0%
Michigan25.0%
California25.0%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
WMed Center for Clinical Research50.0%
Stanford University- Sleep Medicine50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria25.0%
Met criteria75.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Stanford University- Sleep Medicine: < 48 hours
Average response time
  • < 2 Days