CLINICAL DEVELOPMENT OUTLOOK OF OXCARBAZEPINE

Oxcarbazepine (OCBZ) has been accepted for registration as a first-lin e antiepileptic drug (AED) in several countries. However, because of c hanging regulations, studies confirming statistically significant proo f of efficacy are necessary in accordance with new standards. Therefor e, Ciba has initiated a worldwide clinical development program to achi eve registration. Four different types of design to demonstrate statis tically significant proof of efficacy in partial seizures will be init iated. These studies are a ''classical'' poly-therapy add-on study, a monotherapy substitution trial, a high-dose/low-dose active-control mo notherapy study, and a study in presurgical patients.