Felbamate in the treatment of refractory partial-onset seizures.
Felbamate (FBM) is a new antiepileptic drug (AED) that has been tested in open and controlled studies in patients with therapy-refractory partial-onset seizures. Proof of efficacy is based on results of five controlled studies (three with polytherapy and two with monotherapy). In two of the three polytherapy studies, a classic placebo crossover design was used. The third study used a novel design evaluating the efficacy of FBM in a placebo-controlled parallel design in patients completing an evaluation for epilepsy surgery. The primary efficacy variable in this study was the number of patients who experienced a fourth seizure before the end of the study. Forty-six percent of patients randomized to FBM stopped treatment prematurely because of a fourth seizure compared with 88% randomized to placebo. Two studies investigating the efficacy in monotherapy were performed. Both studies used an identical trial design comparing FBM with a low dosage of valproate (VPA). The efficacy of FBM was found to be superior to the low-dosage VPA for both studies. Open long-term follow-up studies have confirmed the long-term efficacy of FBM for up to 12 months. Overall, FBM was well tolerated in both poly- and monotherapy.
Jensen
P K
PK
Schering-Plough Research Institute, Kenilworth, NJ 07033-0539.
D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D004829:Epilepsy, Generalized / Q000188:drug therapy; D000078328:Felbamate; D006801:Humans; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols / Q000627:therapeutic use*; D012107:Research Design; D014635:Valproic Acid / Q000627:therapeutic use
D000927:Anticonvulsants; D048448:Phenylcarbamates; D010919:Placebos; D011409:Propylene Glycols; D014635:Valproic Acid; D000078328:Felbamate