CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 645 enrolled
Drug / intervention
JZP-110drug
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.

Search/NCT02348632
NCT02348632Phase 3Completed
CompareCT.gov

A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

Jazz Pharmaceuticals·interventional·Posted Jan 28, 2015·Updated Jun 25, 2019

In Brief

A Phase 3 clinical trial evaluating JZP-110 for Narcolepsy and Obstructive Sleep Apnea. Completed, enrolled 645 participants across 80 sites in 6 countries.

Detailed Summary

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy, Obstructive Sleep Apnea
CountriesCanada, Finland, France, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartMay 1, 2015
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.4 years ago

Interventions

JZP-110drug