FDA accepts historical controls for epilepsy monotherapy studies
Wednesday, July 21, 2010 - 03:35
in Health & Medicine
New York University researchers revealed that data from previously completed withdrawal to monotherapy studies for antiepileptic drugs (AEDs) provide a valid control for future studies, obviating the need for placebo/pseudo-placebo trials to demonstrate the efficacy of these drugs as monotherapy. Results of this study are now available online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy...