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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Narcolepsy With Cataplexy, Excessive Daytime Sleepiness

Intervention / Treatment
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* Drug: Pitolisant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitolisant<br>Pitolisant at 5, 10, 20 or 40mg | Drug: Pitolisant<br>* 1 capsule in the morning before breakfast<br>* Other names: BF2.649;|
| Placebo Comparator: Placebo<br>Capsules of placebo containing lactose | Drug: Placebo<br>* 1 capsule in the morning before breakfast<br>* Other names: Capsules of placebo containing lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of anticataplectic efficacy | Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week. | At week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive Daytime Sleepiness assessment | Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires. | At week 7 | 
| Safety assessment | Safety assessment thanks to AE recording, vitals signs assessment, ECG... | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcolepsy, Cataplexy, Sleep disorder, Excessive daytime sleepiness