At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 154 enrolled
Drug / intervention
JZP-258 +1 moredrug
Likely dose
Not stated in 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 the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
In Brief
A Phase 3 clinical trial evaluating JZP-258 and Placebo Oral Solution for Idiopathic Hypersomnia. Completed, enrolled 154 participants across 63 sites in 8 countries.
Detailed Summary
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Hypersomnia
CountriesBelgium, Czechia, Finland, France, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartNov 2018
Primary CompletionJun 2020
Study CompletionDec 2020
TodayJul 2026
First PostedMay 22, 2018
Enrollment StartNov 27, 2018
Primary CompletionJun 12, 2020
Study CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.1 years ago
Interventions
JZP-258drug
Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
Placebo Oral Solutiondrug
Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.