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

2014-07-23 21:10:37 | BioPortfolio

Summary

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)

Description

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Narcolepsy

Intervention

BF2.649, Modafinil, Placebo

Location

Neurocenter (EOC) of Southern Switzerland
Lugano
Switzerland
6903

Status

Recruiting

Source

Bioprojet

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:37-0400

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A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)

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