At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 201 enrolled
Drug / intervention
JZP-258 +1 moredrug
Likely dose
JZP-258 0.5 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.
A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
In Brief
A Phase 3 clinical trial evaluating JZP-258 and Placebo for Narcolepsy With Cataplexy. Completed, enrolled 201 participants across 25 sites in 6 countries.
Detailed Summary
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy With Cataplexy
CountriesBelgium, Czechia, Finland, France, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMar 2017
Primary CompletionJan 2019
Study CompletionJul 2019
TodayJul 2026
First PostedJan 25, 2017
Enrollment StartMar 14, 2017
Primary CompletionJan 24, 2019
Study CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.4 years ago
Interventions
JZP-258drug
JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate
Placeboother
Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial \[United States Pharmacopeia/ National Formulary\])