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NEUROLOGY 1983;33:14-25
© 1983 American Academy of Neurology

A design for the prospective evaluation of the efficacy and toxicity of antiepileptic drugs in adults

Richard H. Mattson, Joyce A. Cramer, Antonio V. Delgado Escueta, Dennis B. Smith, Joseph F. Collins, VA Epilepsy Cooperative Study Group, Thomas R. Browne, Wayne E. Crill, Richard W. Homan, Assa Mayersdoif, Charlotte B. McCutchen, James O. McNamara, N. Paul Rosenthal, David M. Treiman, B. Joe Wilder, Peter D. Williamson and Larry M. Young

Epilepsy Center (Dr. Mattson) and Epilepsy Research (Mrs. Cramer), Veterans Administration Medical Center, West Haven, CT, Comprehensive Epilepsy Program (Dr. Escueta), Southwest Veterans Administration Regional Epilepsy Center, Wadsworth Veterans Administration Medical Center, Los Angeles, CA, Neurology Service (Dr. Smith), Veterans Administration Medical Center, Forest Hills Division, Augusta, GA, Cooperative Studies Program Coordinating Center (Dr. Collins), Veterans Administration Medical Center, Perry Point, MD, and Veterans Administration Medical Center, Boston, MA (Dr. Brown), Seattle, WA (Dr. Crill), Dallas, TX (Dr. Homan), Minneapolis, MN (Dr. Mayersdorn, San Diego, CA (Dr. McCutchen), Durham, NC (Dr. McNamara), Sepulveda. CA (Dr. Rosenthal), Los Angeles, CA (Dr. Treiman), Gainesville, FL (Dr. Wilder), West Haven, CT (Dr. Williamson), and Albuquerque, NM (Mr. Young).

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

The design for the comparative evaluation of the efficacy and toxicity of phenobarbital, phenytoin, primidone, and carbamazepine is outlined. A double-blind prospective study of a sufficient number of patients can determine the optimum drug to use initially for partial and generalized tonic-clonic seizures in adults. The rationale for methods defines the major parameters that should be addressed in order to determine optimum drug for longterm seizure therapy. Major problems in the function of such a project include aspects of sample size attainment, screeningh-ecruitment, non-drug-related losses, and adjustments to the ongoing protocol. The design, with modifications, can be used to study other antiepileptic drugs and other types of seizures.

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

Accepted for publication August 26, 1982






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