180
Participants
Start Date
November 30, 2010
Primary Completion Date
April 30, 2012
Study Completion Date
July 31, 2012
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."
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."
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."
Evelyne DESCHAMPS DE PAILLETTE, Paris
Lead Sponsor
Bioprojet
OTHER