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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
Neurocenter (EOC) of Southern Switzerland
Lugano, Switzerland
Cataplexy attacks reported on sleep diary
Time frame: every days from screening visit (day-14) to final visit (day 56)
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
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