Introduction

Abstract

The American Epilepsy Society 2002 Annual Course, entitled “Evaluating the Efficacy of Antiepileptic Treatments,” was held on Sunday, December 1st in Seattle, Washington at the AES Annual Meeting and is summarized in this supplement. The course addressed the process of developing and testing various therapeutic approaches to epilepsy treatment, and then critically reviewed clinical trial data in five specific areas. This supplement includes articles developed by speakers at the course based on their lectures. Dr. Steven White begins with a consideration of how preclinical development influences the design of clinical trials. Next, Dr. Russell Katz discusses clinical trial design from the perspective of the FDA. Dr. Greg Koski then reviews ethical issues in antiepileptic therapeutic trials, with particular attention focused on the changing environment in which these trials are conducted. In the next part of the supplement, clinical trial data in specific areas are critically reviewed by a series of experts. Dr. Edwin Trevethan reviews the special issues in pediatric treatment trials. Dr. Elizabeth Thiele discusses current data on the efficacy of the ketogenic diet and the special issues that make this therapeutic modality difficult to study. Next, Dr. Brian Litt reviews trials of devices for the treatment of epilepsy. Dr. Samuel Weibe then discusses trials of surgical treatment. Finally, Dr. Ed Faught discusses the limited data available concerning the treatment of idiopathic (primary) generalized epilepsies. In the final manuscript, Dr. Frank Gilliam considers the issue of what we do not learn from clinical trials and how this impacts on clinical practice. He considers how those knowledge gaps are best filled and suggests strategies that could allow us to learn more from clinical trials in the future. The goal of the symposium was to educate participants about the process of clinical trials in epilepsy and to critically review trials in several specific areas. We hope that the course and this supplement will enable physicians to better evaluate trial results, claims made based on them, and limitations in their interpretation.