Clinical development outlook of oxcarbazepine.

Oxcarbazepine (OCBZ) has been accepted for registration as a first-line antiepileptic drug (AED) in several countries. However, because of changing regulations, further studies confirming statistically significant proof of efficacy are necessary in accordance with new standards. Therefore, Ciba has initiated a worldwide clinical development program to achieve registration. Four different types of design to demonstrate statistically significant proof of efficacy in partial seizures will be initiated. These studies are a "classical" polytherapy add-on study, a monotherapy substitution trial, a high-dose/low-dose active-control monotherapy study, and a study in presurgical patients.