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Felbamate

A double-blind controlled trial in patients undergoing presurgical evaluation of partial seizures

Cleveland Clinic Foundation (Dr. Bourgeois), Cleveland, OH; the University of Minnesota and MINCEP (Dr. Leppik), Minneapolis, MN; the University of Michigan Medical Center (Dr. Sackellares), Ann Arbor, MI; the Northern California Comprehensive Epilepsy Center (Dr. Laxer), University of California San Francisco Medical Center, San Francisco, CA; Johns Hopkins Hospital (Dr. Lesser), Baltimore, MD; the University of North Carolina School of Medicine (Dr. Messenheimer), North Carolina Memorial Hospital, Chapel Hill, NC; and Wallace Laboratories (Drs. Kramer, Kamin, and Rosenberg), Princeton, NJ.

We studied the efficacy and safety of felbamate, an investigational antiepileptic drug, in a unique, double-blind, placebo-controlled trial. Sixty-four patients with refractory partial-onset seizures who completed a routine evaluation for epilepsy surgery met seizure frequency entry criteria. Each patient received felbamate or placebo in addition to the anticonvulsant regimen present at the conclusion of the presurgical evaluation. The treatment phase consisted of an 8-day inpatient period and a 21-day outpatient period. The efficacy variable was time to fourth seizure. The difference in time to fourth seizure was statistically significant (p = 0.028) in favor of felbamate. Eighty-eight percent of the patients in the placebo group had a fourth seizure during the treatment phase compared with 46% of the patients in the felbamate group (p = 0.001). Adverse experiences with felbamate were generally mild or moderate in severity. This trial demonstrated the ability of felbamate to quickly and safely reduce the occurrence of frequent partial-onset seizures and maintain effective seizure control following reductions in the dosages of standard antiepileptic drugs.

Address correspondence and reprint requests to Dr. Blaise Bourgeois, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195-5221.

Supported by a research grant from Wallace Laboratories, Division of Carter-Wallace, Inc., Cranbury, NJ.

Received May 15,1992. Accepted for publication in final form August 19, 1992.

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