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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800045
First Posted: February 27, 2013
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bioprojet
  Purpose

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 Intervention Phase
Narcolepsy With Cataplexy Excessive Daytime Sleepiness Drug: Pitolisant Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Excessive Daytime Sleepiness assessment [ Time Frame: At week 7 ]
    Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.

  • Safety assessment [ Time Frame: 11 weeks ]
    Safety assessment thanks to AE recording, vitals signs assessment, ECG...


Enrollment: 103
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitolisant
Pitolisant at 5, 10, 20 or 40mg
Drug: Pitolisant
1 capsule in the morning before breakfast
Other Name: BF2.649
Placebo Comparator: Placebo
Capsules of placebo containing lactose
Drug: Placebo
1 capsule in the morning before breakfast
Other Name: Capsules of placebo containing lactose

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800045


Locations
Hungary
State Health Center
Budapest, Hungary, 1134
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Evelyne De Paillette, Dr Bioprojet
  More Information

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01800045     History of Changes
Other Study ID Numbers: P11-05 / Pitolisant
2012-003076-39 ( EudraCT Number )
First Submitted: February 13, 2013
First Posted: February 27, 2013
Last Update Posted: August 31, 2016
Last Verified: July 2015

Keywords provided by Bioprojet:
Narcolepsy
Cataplexy
Sleep disorder
Excessive daytime sleepiness

Additional relevant MeSH terms:
Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders