Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

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)


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Enrollment: 110
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Arms:
- Experimental: BF2.649
- Active Comparator: Modafinil
- Placebo Comparator: Placebo