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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

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.

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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.

Conditions

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Narcolepsy With Cataplexy Excessive Daytime Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pitolisant

Pitolisant at 5, 10, 20 or 40mg

Group Type EXPERIMENTAL

Pitolisant

Intervention Type DRUG

1 capsule in the morning before breakfast

Placebo

Capsules of placebo containing lactose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule in the morning before breakfast

Interventions

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Pitolisant

1 capsule in the morning before breakfast

Intervention Type DRUG

Placebo

1 capsule in the morning before breakfast

Intervention Type DRUG

Other Intervention Names

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BF2.649 Capsules of placebo containing lactose

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No