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Clinical Development Outlook of Oxcarbazepine
Author(s) -
Schwabe Stefan
Publication year - 1994
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.1994.tb05940.x
Subject(s) - oxcarbazepine , medicine , clinical trial , clinical efficacy , antiepileptic drug , epilepsy , pharmacology , psychiatry , carbamazepine
Summary: 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” poly‐therapy add‐on study, a monotherapy substitution trial, a high‐dose/low‐dose active‐control monotherapy study, and a study in presurgical patients. Anticonvulsants