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A Randomized, Double Blind Study Comparing Pitolisant (BF2.649) to Placebo in Two Parallel Groups on the Weekly Frequency of Cataplexy Attacks and Excessive Daytime Sleepiness in Narcoleptic Patients With Cataplexy.
Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week). The patients will be treated during 7 weeks with Pitolisant or placebo.
The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo. The safety will also be assessed.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
State Health Center
Budapest, Hungary
Start Date
April 1, 2013
Primary Completion Date
January 1, 2015
Completion Date
January 1, 2015
Last Updated
August 31, 2016
103
ACTUAL participants
Pitolisant
DRUG
Placebo
DRUG
Lead Sponsor
Bioprojet
NCT07363720
NCT06872593
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