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Neurology 2003;60:S13-S25
© 2003 American Academy of Neurology

Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represent the opinions of the authors and are not endorsed by nor do they reflect the views of the American Academy of Neurology, Editor-in-Chief, or Associate Editors of Neurology.

Conversion to monotherapy

Clinical trials in patients with refractory partial seizures

Ahmad Beydoun, MD and Ekrem Kutluay, MD

From the Department of Neurology, University of Michigan Health System, Ann Arbor, MI.

Address correspondence and reprint requests to Dr. Ahmad Beydoun, Department of Neurology, University of Michigan Health System, UH1B300/0036, Ann Arbor, MI 48109.

The efficacy, tolerability, and safety of a potential antiepileptic drug (AED) are initially evaluated in clinical trials employing add-on designs. When positive, those trials allow us only to conclude that the study drug is efficacious when administered as adjunctive therapy. However, to demonstrate efficacy and safety as monotherapy, the drug must be evaluated using a monotherapy trial design. Such a design needs to take into account important methodologic issues that can affect clinical relevance and/or raise ethical concerns. This review critically assesses two monotherapy trial designs: outpatient conversion to monotherapy and presurgical conversion to monotherapy in patients with medically refractory seizures of partial onset. The efficacy and safety data derived from published studies of AED monotherapy in patients with partial-onset seizures that utilize these trial designs are evaluated and the advantages and disadvantages of each trial design are discussed.




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