Few drugs have been approved by the Food and Drug Administration specifically for the treatment of pediatric patients with epilepsy in the United States. There are many factors that make tests of drugs in this group different from studies among adults. This report reviews issues that must be considered in designing studies that will help bring to market antiepileptic drugs for children. Information on the wide variety of antiepileptic drugs rapidly being developed can only be obtained through well-controlled, well-designed clinical trials. Despite the obstacles and pitfalls, trials among the pediatric population are necessary to establish the unique efficacy and safety profile of each drug and to determine the target population most likely to benefit from each drug. (J Child Neurol 1994;9(Suppl):S26-S32)
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