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Principles in designing clinical trials for antiepileptic drugs

Comprehensive Epilepsy Program (Dr. Escueta), Southwest Veterans Administration Regional Epilepsy Center, Wadsworth Veterans Administration Medical Center, Los Angeles, CA, Epilepsy Center (Dr. Mattson) and Epilepsy Research (Mrs. Cramer), Veterans Administration Medical Center, West Haven, CT, Neurology Service (Dr. Smith), Veterans Administration Medical Center, Forest Hills Division, Augusta, GA, Cooperative Studies Program Support Center (Dr. Collins), Veterans Administration Medical Center, Perry Point, MD.

Address correspondence and reprint requests to Mrs. Cramer, Study Coordinator, Epilepsy Research (1271, Veterans Administration Medical Center, West Haven, CT 06516.

The failure of previous studies to indicate clear differences in the relative seizure control and side effects of the major antiepileptic drugs has resulted from insufficient clinical trials or limitations in earlier studies. The principles for designing studies of the efficacy and toxicity of major antiepileptic drugs are outlined. These standards apply to the evaluation of new and old antiepileptic drugs used for all types of seizures in diverse populations.

Supported by the Veterans Administration Medical Research Service Cooperative Studies Program.

Accepted for publication August 26, 1982