Excessive Daytime Sleepiness Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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