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Felbamate in the Treatment of Refractory Partial‐Onset Seizures
Author(s) -
Jensen Peder K.
Publication year - 1993
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.1993.tb04591.x
Subject(s) - felbamate , refractory (planetary science) , partial seizures , medicine , complex partial seizures , pediatrics , epilepsy , anticonvulsant , psychology , psychiatry , temporal lobe , physics , astrobiology
Summary: 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 the occurrence 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.