Current opinion in neurology
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This review discusses the interpretation of regulatory randomized controlled trials of antiepileptic drugs. An ever increasing number of drugs have been licensed, more so for add-on treatment than for monotherapy. Regulatory trials constitute the main body of evidence to inform clinical decisions about their use. Designs of regulatory trials for monotherapy are the most controversial as regulators take different views as to the type of designs that are required, which has implications for interpretation and for the risks to which patients are exposed. ⋯ Regulatory trials continue to have major limitations for informing clinical decisions and this should be addressed.