Clinical Trial: "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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 Treatmen
Brief 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.
Detailed Summary:
Sponsor: Jazz Pharmaceuticals
Current Primary Outcome:
- Maintenance of Wakefulness Test (MWT): Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12 [ Time Frame: 12 Weeks ]
- Epworth Sleepiness Scale (ESS): Change in ESS score from Baseline to Week 12 [ Time Frame: 12 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient Global Impression of change (PGIc): Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12 [ Time Frame: 12 Weeks ]
Original Secondary Outcome: Same as current
Information By: Jazz Pharmaceuticals
Dates:
Date Received: January 15, 2015
Date Started: May 2015
Date Completion: March 2017
Last Updated: November 30, 2016
Last Verified: September 2016
