Clinical Trial: Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Sleepi

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Bioprojet

Current Primary Outcome: Measure of anticataplectic efficacy [ Time Frame: At week 7 ]

Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.


Original Primary Outcome: Measure of anticataplectic efficacy [ Time Frame: At week 49 ]

Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.


Current Secondary Outcome:

  • Excessive Daytime Sleepiness assessment [ Time Frame: At week 7 ]
    Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.
  • Safety assessment [ Time Frame: 11 weeks ]
    Safety assessment thanks to AE recording, vitals signs assessment, ECG...


Original Secondary Outcome: Same as current

Information By: Bioprojet

Dates:
Date Received: February 13, 2013
Date Started: April 2013
Date Completion:
Last Updated: August 30, 2016
Last Verified: July 2015