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The demonstration of efficacy and safety of a new antiepileptic drug (AED) almost invariably is based upon well-established placebo-controlled adjunctive therapy studies in patients with drug-resistant focal epilepsy. Ethical and practical concerns, however, are emerging. A large number of AEDs are currently available, and it is difficult to recruit patients and then to retain them in a trial for several months to include baseline, titration, and maintenance periods, while they may worsen if assigned to placebo or ineffective drug groups. Individuals with drug-resistant seizure disorders are at higher risk of sudden unexplained death in epilepsy (SUDEP),1 and there is a decreased SUDEP risk for patients who received active treatment compared to individuals who were randomized to placebo.2
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- © 2015 American Academy of Neurology
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