Journal article
Efficacy and safety of retigabine/ezogabine as adjunctive therapy in adult Asian patients with drug-resistant partial-onset seizures: A randomized, placebo-controlled Phase III study
KS Lim, N Lotay, R White, P Kwan
Epilepsy and Behavior | ACADEMIC PRESS INC ELSEVIER SCIENCE | Published : 2016
Abstract
Purpose The purpose of this study was to evaluate the efficacy and safety of adjunctive retigabine/ezogabine (RTG/EZG) therapy in Asian adults with partial-onset seizures. Methods A Phase III, randomized, double-blind, placebo-controlled, parallel-group study was conducted at 26 centers in Asia. Eligible patients were randomized in a 1:1:1 ratio to receive RTG/EZG 600 mg/day (200 mg 3 times daily), RTG/EZG 900 mg/day (300 mg 3 times daily), or placebo. The study consisted of an 8-week screening/baseline phase, followed by a 16-week treatment phase (4-week titration phase and 12-week maintenance phase). Results The study was terminated early because of emerging safety information on RTG/EZG (..
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Funding Acknowledgements
This study was funded by GlaxoSmithKline. All authors met the International Committee for Medical Journal Editors criteria for authorship, were fully involved in manuscript development, and assume responsibility for the direction and content of the manuscript. K-SL had a major role in the acquisition, analysis, and interpretation of data; PK was involved in concept and study design, and acquisition, analysis, and interpretation of data; and NL and RW were involved in data analysis and interpretation.