Status:
COMPLETED
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Lead Sponsor:
Bioprojet
Conditions:
Narcolepsy With Cataplexy
Excessive Daytime Sleepiness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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). Th...
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 result...
Eligibility Criteria
Inclusion
- Main
- Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks
- ESS \> or = 12
- ICF signed and dated
- Main
Exclusion
- Other conditions that could generate EDS
- Psychological and neurological disorders
- Acute or chronic severe disease
- Treatment by prohibited medication
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01800045
Start Date
April 1 2013
End Date
January 1 2015
Last Update
August 31 2016
Active Locations (1)
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1
State Health Center
Budapest, Hungary, 1134