Clinical Trial: A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Brief Summary: This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.

Detailed Summary: Subjects will be transitioned to JZP-258 based on their treatment status at study entry. All subjects will begin JZP-258 treatment at the beginning of this period and continue through Week 12. They will be treated with JZP-258 alone for the final two weeks of this 12-week period. Once the JZP-258 dose has been optimized per the Investigator's judgment, these subjects may enter the 2-week Stable-Dose Period with that dose. Subjects are eligible to enter the Double-Blind Randomized-Withdrawal Period if the dose of JZP-258 remains unchanged during the Stable-Dose Period and, in the judgment of the Investigator, no clinically significant worsening in narcolepsy symptoms or clinically significant adverse events due to JZP-258 treatment have occurred. Subjects will return for a Safety Follow-up visit 2 weeks after the Double-Blind Randomized-Withdrawal Period.
Sponsor: Jazz Pharmaceuticals

Current Primary Outcome: Change in weekly number of cataplexy attacks [ Time Frame: Two weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in the Epworth Sleepiness Scale (ESS) score [ Time Frame: Two weeks ]

Original Secondary Outcome: Same as current

Information By: Jazz Pharmaceuticals

Dates:
Date Received: January 23, 2017
Date Started: January 2017
Date Completion: November 2018
Last Updated: April 26, 2017
Last Verified: April 2017