Clinical Trial: Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy
Brief Summary: The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
Detailed Summary:
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
Sponsor: Bioprojet
Current Primary Outcome: Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]
- Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ]
- Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ]
Original Secondary Outcome: Same as current
Information By: Bioprojet
Dates:
Date Received: February 9, 2010
Date Started: October 2009
Date Completion:
Last Updated: February 8, 2013
Last Verified: June 2012
