CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
JZP-258drug
Likely dose
JZP-258 6 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04794491
NCT04794491Phase 4Completed
CompareCT.gov

A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of Narcolepsy

Jazz Pharmaceuticals·interventional·Posted Mar 12, 2021·Updated Jan 9, 2024

In Brief

A Phase 4 clinical trial evaluating JZP-258 for Narcolepsy. Completed, enrolled 62 participants across 28 sites.

Detailed Summary

The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 12, 2021
Enrollment StartMar 22, 2021
Primary CompletionNov 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.3 years ago

Interventions

JZP-258drug

Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose \> 6 g