NCT01800045

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Narcolepsy With Cataplexy
• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	Pitolisant	1 capsule in the morning before breakfast
DRUG	Placebo	1 capsule in the morning before breakfast

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-02-27
• Last updated: 2016-08-31

Locations

1 site across 1 country: Hungary