Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) (HARMONYIII)
This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up)|
- Incidence of Treatment Emergent Adverse Event (TEAE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Number of Treatment Emergent Adverse Event (TEAE)
- efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale) [ Time Frame: 12 months ] [ Designated as safety issue: No ]change from baseline of the score of Epworth Sleepiness Scale score (ESS) and calculation of the rate of responders defined as a reduction of 3 points of the ESS score from baseline or the normalization of the ESS score at 10 or below
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
5,10,20,or 40 mg per day, in a once daily scheme
Other Name: Pitolisant
In narcoleptic patients, results obtained in the previous studies showed that BF2.649 reduced significantly the diurnal somnolence compared to placebo confirming its wakening effect against EDS and demonstrating its anti-cataplectic effect when administrated on an individual titration scheme established on basis of individual benefit/tolerance ratio.This long-term safety pragmatic study will provide information about long-term treatment of BF2.649, and also allow patients who satisfy of BF2.649 treatment in previous or on-going studies of Bioprojet continuing to benefit this product.This is an open-label, naturalistic pragmatic, prospective longitudinal uncontrolled, multi-centre international trial assessing the safety and effect of long-term therapy of BF2.649 in treatment of excessive daytime sleepiness in narcolepsy, on 12-month follow-up.