Double-blind, placebo-controlled evaluation of cinromide in patients with the Lennox-Gastaut Syndrome. The Group for the Evaluation of Cinromide in the Lennox-Gastaut Syndrome

Abstract

This study evaluated the effects of cinromide in patients with Lennox-Gastaut Syndrome. No difference between cinromide and placebo was shown in terms of seizure reduction or global evaluations. This study is important, however, because it represents an effort to overcome methodologic difficulties inherent in evaluating this population, and because a substantial placebo response was demonstrated. The need for well-designed, placebo-controlled clinical studies of potential antiepileptic drugs, even in an especially refractory and mentally impaired population, is underscored by the study's outcome.