Prototype Antiepileptic Drug Clinical Development Plan |
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Authors: | Lynn D. Kramer Gordon W. Pledger Marc Kamin |
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Affiliation: | The R. W. Johnson Pharmaceutical Research Institute, Spring House, Pennsylvania;Clinical Research, Wallace Laboratories, Division of Carter-Wallace, Princeton, New Jersey, U.S.A. |
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Abstract: | Antiepileptic drug (AED) development has been generally difficult owing to many factors: regulatory requirements for demonstration of efficacy and safety, subject availability, traditional trial designs, and physicians' beliefs about epilepsy and its treatment. The U.S. Food and Drug Administration (FDA) regulations require a new drug to be shown safe and effective for its intended use before it can be marketed. The unambiguous proof required is a formidable hurdle for AED development. We report a recent clinical development plan highlighting innovations in clinical trial design that have addressed these requirements, discuss alternative endpoints, and compare the results of various trial designs at various stages of development. This model clinical development plan includes trials relevant to all three clinically relevant contexts in which an AED might be used: as an adjunct to an existing regimen, as a substitution for much of an existing AED regimen, and as monotherapy. |
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Keywords: | Anticonvulsants Drug development Clinical trials Felbamate Drug toxicity |
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