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NEUROLOGY 1987;37:963
© 1987 American Academy of Neurology

A controlled study of progabide in partial seizures

Methodology and results

I. E. Leppik, MD, F. E. Dreifuss, MD, R. Porter, MD, T. Bowman, RN, N. Santilli, RN, M. Jacobs, MS, C. Crosby, MS, J. Cloyd, PharmD, J. Stackman, MD, N. Graves, PharmD, T. Sutula, MD, PhD, T. Welty, PharmD, J. Vickery, MD, R. Brundage, PharmD, J. Gates, MD, R. J. Gumnit, MD and A. Gutierrez, MD

Comprehensive Epilepsy Program (Dr. Leppik, Ms. Bowman and Jacobs, Drs. Cloyd, Graves, Welty, Brundage, Gates, and Gumnit), the Department of Neurology (Dr. Leppik), and the College of Pharmacy (Drs. Cloyd and Graves), University of Minnesota, Minneapolis, MN the University of Virginia (Dr. Dreifuss, Ms. Santilli and Crosby, Drs. Stackman, Sutula, Vickery, and Gutierrez), Charlottesville, VA; the Department of Neurology (Dr. Leppik), St. Paul-Ramsey Medical Center/Ramsey Clinic, St. Paul, MN and the National Institutes of Health (Dr. Porter), Bethesda, MD.

The results of a multicenter, double-blind, placebo-controlled clinical trial of the efficacy and safety of progabide (PGB) in the treatment of partial seizures are presented. This study was performed with a number of rigorous controls not usually present in clinical trials. These included uniform co-medication in which all patients received only phenytoin and carbamazepine; concentrations of these two drugs were maintained within narrow, predefined concentration ranges. There was no statistically significant difference between PGB and placebo in seizure frequency and seizure duration for most of the analyses performed. One patient was withdrawn from the study because of hepatotoxicity. PGB was associated with a significant inhibition of phenytoin but not carbamazepine clearance. The results of this study indicate that PGB was not a potent antiepileptic drug in this population of persons with intractable epilepsy.

Address correspondence and reprint requests to Dr. Leppik, 2701 University Avenue Southeast, Suite 106, Minneapolis, MN 55414.

Presented in part at the thirty-seventh annual meeting of the American Academy of Neurology, Dallas, TX, April 1985.

Supported by NINCDS contracts #N01-NS-1–2371 Task Order 1 and #NOl-NS-1–2367 Task Order 1.

Received July 28, 1986. Accepted for publication in final form October 2, 1986.




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