The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)
BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies. The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary. 60 patients with narcolepsy with or without cataplexy will be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Neurocenter (EOC) of Southern Switzerland
Lugano, Switzerland
Epworth Sleepiness Scale (ESS)
Time frame: between baseline and at the end of 8 week DB phase
Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks
Time frame: 14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time frame: at inclusion and after 8-week treatment
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