Felbamate monotherapy: Controlled trial in patients with partial onset seizures
- 1 September 1992
- journal article
- clinical trial
- Published by Wiley in Annals of Neurology
- Vol. 32 (3) , 386-392
- https://doi.org/10.1002/ana.410320313
Abstract
Felbamate (FBM) monotherapy was evaluated in 44 patients with uncontrolled partial onset seizures in a unique, single‐center, randomized, double‐blind, parallel‐group trial. During the 56‐day baseline period, patients were required to have at least 8 seizures and to be receiving only one standard antiepileptic drug (AED) at a therapeutic level; a second AED was allowed if at a subtherapeutic level. Patients were randomized to valproate (VPA), 15 mg/kg, or to FBM, 3,600 mg/day. In the treatment phase, previous AEDs were discontinued by study day 28 (by one‐third decrements on study days 1, 14, and 28). Study end points were completion of 112 study days or the fulfilling of escape criteria. Criteria for escape relative to baseline were: two‐fold increase in monthly seizure frequency, two‐fold increase in highest 2‐day seizure frequency, single generalized tonic‐clonic seizure (GTC) if none occurred during baseline, or significant prolongation of GTCs. The predetermined primary efficacy variable was the number of patients escaping in each treatment group. Nineteen patients on VPA and 3 on FBM met escape criteria (p < 0.001, chi‐square test). When overall seizure frequency among study completers was compared with baseline, the FBM group had a 50 to 65% reduction in seizure frequency. FBM adverse experiences were all mild or moderate in severity, and the incidence of adverse experiences was lower in monotherapy. FBM monotherapy was effective in the treatment of partial onset seizures with or without generalization and demonstrated a favorable safety profile.Keywords
This publication has 16 references indexed in Scilit:
- Clinical Trials of Investigational Antiepileptic Drugs: Monotherapy DesignsEpilepsia, 1991
- Discontinuation of Phenytoin and Carbamazepine in Patients Receiving FelbamateEpilepsia, 1991
- Felbamate: A Clinical Trial for Complex Partial SeizuresEpilepsia, 1991
- Effect of Felbamate on Plasma Levels of Carbamazepine and Its MetabolitesEpilepsia, 1991
- Hazards of Inference: The Active Control InvestigationEpilepsia, 1989
- Comparison of Carbamazepine, Phenobarbital, Phenytoin, and Primidone in Partial and Secondarily Generalized Tonic–Clonic SeizuresNew England Journal of Medicine, 1985
- CORRELATION BETWEEN PLASMA CARBAMAZEPINE‐10,11‐EPOXIDE CONCENTRATION AND DRUG SIDE‐EFFECTS IN CHILDREN WITH EPILEPSYDevelopmental Medicine and Child Neurology, 1984
- Proposal for Revised Clinical and Electroencephalographic Classification of Epileptic SeizuresEpilepsia, 1981
- Comparison of Sodium Valproate and Phenytoin as Single Drug Treatment in EpilepsyEpilepsia, 1981