At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
Xyremdrug
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 Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
In Brief
A Phase 3 clinical trial evaluating Xyrem for Narcolepsy With Cataplexy. Completed, enrolled 106 participants across 20 sites in 4 countries.
Detailed Summary
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy With Cataplexy
CountriesFrance, Italy, Netherlands, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartOct 2014
Primary CompletionFeb 2017
Study CompletionJan 2019
TodayJul 2026
First PostedAug 21, 2014
Enrollment StartOct 1, 2014
Primary CompletionFeb 1, 2017
Study CompletionJan 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.9 years ago
Interventions
Xyremdrug