Sleep Disorders Clinical Trial
Official title:
Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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