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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Bioprojet
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01800045
First received: February 13, 2013
Last updated: May 15, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 49 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.

  • Safety assessment [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
    Safety assessment thanks to AE recording, vitals signs assessment, ECG...


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Evelyne De Paillette, Dr 0033 (0)1 47 03 66 33 e.depaillette@bioprojet.com

Locations
Hungary
State Health Center Recruiting
Budapest, Hungary, 1134
Contact: Zoltan SZAKACS, Pr    +36209364140    szakacs001@t-online.hu   
Principal Investigator: Zoltan SZAKACS, Pr         
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Evelyne De Paillette, Dr Bioprojet
  More Information

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01800045     History of Changes
Other Study ID Numbers: P11-05 / Pitolisant, 2012-003076-39
Study First Received: February 13, 2013
Last Updated: May 15, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Macedonia: Ministry of Health
Ukraine: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 29, 2014