At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 476 enrolled
Drug / intervention
JZP-110 +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 Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
In Brief
A Phase 3 clinical trial evaluating JZP-110 and Placebo oral tablet for Obstructive Sleep Apnea. Completed, enrolled 476 participants across 59 sites in 5 countries.
Detailed Summary
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesCanada, France, Germany, Netherlands, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMay 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedJan 28, 2015
Enrollment StartMay 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.4 years ago
Interventions
JZP-110drug
Placebo oral tabletdrug