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

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ClinicalTrials.gov Identifier: NCT01800045
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Tracking Information
First Submitted Date  ICMJE February 13, 2013
First Posted Date  ICMJE February 27, 2013
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
Measure of anticataplectic efficacy [ Time Frame: At week 49 ]
Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
  • 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...
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Official Title  ICMJE 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.
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Narcolepsy With Cataplexy
  • Excessive Daytime Sleepiness
Intervention  ICMJE
  • Drug: Pitolisant
    1 capsule in the morning before breakfast
    Other Name: BF2.649
  • Drug: Placebo
    1 capsule in the morning before breakfast
    Other Name: Capsules of placebo containing lactose
Study Arms  ICMJE
  • Experimental: Pitolisant
    Pitolisant at 5, 10, 20 or 40mg
    Intervention: Drug: Pitolisant
  • Placebo Comparator: Placebo
    Capsules of placebo containing lactose
    Intervention: Drug: Placebo
Publications * Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC; HARMONY-CTP study group. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Mar;16(3):200-207. doi: 10.1016/S1474-4422(16)30333-7. Epub 2017 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
103
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2013)
120
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01800045
Other Study ID Numbers  ICMJE P11-05 / Pitolisant
2012-003076-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioprojet
Study Sponsor  ICMJE Bioprojet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Evelyne De Paillette, Dr Bioprojet
PRS Account Bioprojet
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP