Innovative clinical trial designs for future antiepileptic drugs.

Pharmacoresistance continues to be a challenging problem for a substantial number of epileptic patients and their attending physicians. In the past 10 years, we have made little progress in reducing the incidence of refractory epilepsy and have no innovative plans in place with the potential to do so. In this article, I propose two radical solutions to our present dilemma. The first involves the use of a novel clinical trial design that will rapidly screen for antiepileptic drugs with the highest safety and efficacy profiles. The second focuses on the prevention of epilepsy. The success of these approaches will depend upon our ability to identify individuals at high risk of developing epilepsy and to initiate effective and innovative clinical trial paradigms that will be able to identify more effective antiepileptic or antiepileptogenic agents. It will likely require significant changes from our current strategies to accomplish these goals.