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

Sponsor

Bioprojet (Other)

Overall Status

Completed

CT.gov ID

NCT01800045

Collaborator

(none)

103

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy With Cataplexy Excessive Daytime Sleepiness	Drug: Pitolisant Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitolisant Pitolisant at 5, 10, 20 or 40mg	Drug: Pitolisant 1 capsule in the morning before breakfast Other Names: BF2.649
Placebo Comparator: Placebo Capsules of placebo containing lactose	Drug: Placebo 1 capsule in the morning before breakfast Other Names: Capsules of placebo containing lactose

Arm

Intervention/Treatment

Experimental: Pitolisant

Pitolisant at 5, 10, 20 or 40mg

Drug: Pitolisant

1 capsule in the morning before breakfast

Other Names:

BF2.649

Placebo Comparator: Placebo

Capsules of placebo containing lactose

Drug: Placebo

1 capsule in the morning before breakfast

Other Names:

Capsules of placebo containing lactose

Outcome Measures

Primary Outcome Measures

Measure of anticataplectic efficacy [At week 7]
Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.

Secondary Outcome Measures

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