This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01800045
First received: February 13, 2013
Last updated: August 30, 2016
Last verified: July 2015
  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: Double Blind (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: February 13, 2013
Last Updated: August 30, 2016

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

ClinicalTrials.gov processed this record on June 23, 2017