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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Narcolepsy With Cataplexy Excessive Daytime Sleepiness Drug: Pitolisant Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
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.
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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...


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Hungary
State Health Center
Budapest, Hungary, 1134
Sponsors and Collaborators
Bioprojet
Investigators
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Study Director: Evelyne De Paillette, Dr Bioprojet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01800045    
Other Study ID Numbers: P11-05 / Pitolisant
2012-003076-39 ( EudraCT Number )
First Posted: February 27, 2013    Key Record Dates
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:
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Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Sleepiness
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders