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

Phase 3

Completed

• Conditions: Narcolepsy With Cataplexy; Excessive Daytime Sleepiness
• Interventions: Drug: Placebo; Drug: Pitolisant

• Registration Number: NCT01800045
• Lead Sponsor: Bioprojet

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 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 Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Study Start: 2013-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-07
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks
• ESS > or = 12
• ICF signed and dated

Main

Exclusion Criteria

• Other conditions that could generate EDS
• Psychological and neurological disorders
• Acute or chronic severe disease
• Treatment by prohibited medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules of placebo containing lactose
Pitolisant	Pitolisant	Pitolisant at 5, 10, 20 or 40mg

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

State Health Center; 🇭🇺 Budapest, Hungary