Clinical Trial: Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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, Followed by

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Bioprojet

Current Primary Outcome: Incidence of Treatment Emergent Adverse Event (TEAE) [ Time Frame: 12 months ]

Number of Treatment Emergent Adverse Event (TEAE)


Original Primary Outcome: Incidence of TEAE [ Time Frame: 12 months ]

Number of TEAE


Current Secondary Outcome: efficacy on EDS as measured by ESS ( Epworth Sleepiness Scale) [ Time Frame: 12 months ]

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


Original Secondary Outcome: Same as current

Information By: Bioprojet

Dates:
Date Received: June 21, 2011
Date Started: May 2011
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017