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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
1 capsule in the morning before breakfast
1 capsule in the morning before breakfast
State Health Center
Budapest, Hungary
Measure of anticataplectic efficacy
Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.
Time frame: At week 7
Excessive Daytime Sleepiness assessment
Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.
Time frame: At week 7
Safety assessment
Safety assessment thanks to AE recording, vitals signs assessment, ECG...
Time frame: 11 weeks
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