NCT02348593

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

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 Narcolepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (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, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	JZP-110
DRUG	Placebo oral tablet

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-01-28
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

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