NCT01067222

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Narcolepsy
• Excessive Daytime Sleepiness
• Cataplexy
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	BF2.649	BF2.649 oral capsules at 10 or 20 or 40 mg per day
DRUG	Modafinil	Modafinil oral capsules at 100 or 200 or 400 mg per day
DRUG	Placebo	Placebo oral capsules, 4 capsules per day

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2010-02-11
• Last updated: 2012-06-11

Locations

1 site across 1 country: Switzerland