Perspective of the Participating Investigator

Abstract

This chapter is written with a perspective of 20 years of clinical trials in the study of epilepsy and anticonvulsant drugs. At the beginning of this period, no new anticonvulsant drug had been entered into therapeutic use in the United States for approximately eight years. Epileptic seizures were not then categorized with great accuracy and, as described by Coats worth [1], there had been few adequate clinical trials even for those drugs in common use as antiepileptic agents. Only few clinical trials included electroencephalography (EEG) as an aid to seizure identification, and no objective measurements of seizure frequency were available. During the past 20 years, certain principles have been developed for clinical evaluation of antiepileptic drugs and certain protocol formats have proven reliable in the evaluation of anticonvulsant drugs against specific seizure types. Guidelines for the evaluation of antiepileptic drugs have been formulated [2, 3]. Modern trials require admission criteria; exclusion criteria; careful preplanning of trial duration, study design, and methods of assignment randomly to a study group and a control group; the use of a test drug and a placebo; a fixed dosage schedule; and a double-blind methodology designed for the control of bias.