Clinical Trials Relating to Epilepsy

Abstract

As with all clinical trials, clinical trials in the epilepsies must, of necessity, be designed to deal with certain peculiarities of the disorder. The first important concept in the design of trials is the recognition that many different syndromes are included in the epilepsies and that meaningful data cannot be collected from an undifferentiated group of epileptic persons. Fortunately, very empirical information — the clinical seizure type — has rather good correlation with the various therapeutic measures and seizure classifications [2]. These data are useful as a first step in obtaining some form of homogeneity among the patients to be studied. This brief summary will concentrate on variables important in the clinical trials of new antiepileptic drugs; even though clinical trials of other therapeutic modalities (such as biofeedback or surgery) are quite important and remain in a relatively primitive state of development, most persons with epilepsy are treated with antiepileptic drugs, and most patients who remain uncontrolled on drugs are hopeful for the development of new, less toxic, and more effective medications. This communication will also be limited to a discussion of controlled clinical trials of antiepileptic drugs, in children and adults, exclusive of infantile spasms.