A Phase 3 interventional study of Pitolisant and Placebo in Narcolepsy With Cataplexy and Excessive Daytime Sleepiness, sponsored by Bioprojet. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by Bioprojet · Phase 3, Interventional, and Treatment
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 103 is below the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →Bioprojet is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Main Inclusion Criteria:
Main Exclusion Criteria:
Pitolisant at 5, 10, 20 or 40mg
Drug: Pitolisant
Capsules of placebo containing lactose
Drug: Placebo
1 capsule in the morning before breakfast
Also known as: BF2.649
1 capsule in the morning before breakfast
Also known as: Capsules of placebo containing lactose
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
The record gives a start of Apr 2013, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pitolisant
Bioprojet