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

PHASE3CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

December 31, 2010

Conditions
NarcolepsyExcessive Daytime SleepinessCataplexySleep Disorders
Interventions
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

Trial Locations (1)

6903

Neurocenter (EOC) of Southern Switzerland, Lugano

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioprojet

OTHER