Antiepileptic drugs | Clinical drug development in epilepsy

Clinical drug development in epilepsy is characterized by a succession of trials with the principal aim of bringing a new compound to market. This article reviews the development process from first human exposure through regulatory approval to postmarketing evaluation. The basic principles of clinical trial design are examined and their application – in Phase I studies in healthy volunteers and in Phase II and Phase III studies in epilepsy patients – discussed. Monotherapy studies, the differing requirements of individual regulatory authorities, and the limitations of antiepileptic drug trials – particularly with regard to their ability to inform everyday clinical practice – are also considered