Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

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.

Inclusion Criteria:

• diagnosis of narcolepsy with or without cataplexy
• patients need to free of or discontinue psychostimulant medications for at least 14 days,
• patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
• patients must have adequate support to comply with the entire study requirements

Exclusion Criteria:

• Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
• Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
• Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
• Current or recent history of a substance abuse or dependence disorder including alcohol abuse