NCT02348606

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	JZP-110
DRUG	Placebo oral tablet

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-01-28
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

59 sites across 5 countries: United States, Canada, France, Germany, Netherlands