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Completed

NCT Number: NCT01800045

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

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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Key information

Conditions

Narcolepsy With Cataplexy Cataplexy Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Mental Disorders Narcolepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Health Center

Budapest, 1134, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitolisant

Drug

1 capsule in the morning before breakfast

Other names: BF2.649

Placebo

Drug

1 capsule in the morning before breakfast

Other names: Capsules of placebo containing lactose

Primary outcomes

  1. Measure of anticataplectic efficacy

    Time frame: At week 7

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

Secondary outcomes

  1. Excessive Daytime Sleepiness assessment

    Time frame: At week 7

    Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.

  2. Safety assessment

    Time frame: 11 weeks

    Safety assessment thanks to AE recording, vitals signs assessment, ECG...

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2013
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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