Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

July 31, 2012

Conditions
Treatment of Excessive Daytime Sleepiness in Narcolepsy
Interventions
DRUG

BF2.649

"BF2.649 is provided in capsules. One-quarter or one-half of BF2.649 tablet at 20 mg (corresponding to 5-, and 10 mg, respectively).~Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."

DRUG

Vigil

"Modafinil is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.~Modafinil tablet at 100 mg are enclosed in gelatine capsules. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."

DRUG

palcebo

"placebo is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.~placebo consist of identical capsules containing lactose only. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."

Trial Locations (1)

75002

Evelyne DESCHAMPS DE PAILLETTE, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioprojet

OTHER

NCT01638403 - Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. | Biotech Hunter | Biotech Hunter