Clinical Trials Directory

Trials / Completed

CompletedNCT02348632

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
645 (actual)
Sponsor
Jazz Pharmaceuticals · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGJZP-110

Timeline

Start date
2015-05-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2015-01-28
Last updated
2019-06-25
Results posted
2019-06-25

Locations

80 sites across 6 countries: United States, Canada, Finland, France, Germany, Netherlands

Source: ClinicalTrials.gov record NCT02348632. Inclusion in this directory is not an endorsement.

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA" (NCT02348632) · Clinical Trials Directory