Pooled efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Data from four double‐blind placebo‐controlled pivotal phase III clinical studies

Summary Purpose Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added‐on to stable antiepileptic therapy in adults with focal‐onset seizures. Methods Data from 1703 patients enrolled in four phase III double‐blind, randomized, placebo‐controlled studies were pooled and analyzed. Following a 2 week titration period, ESL was administered at 400 mg, 800 mg, and 1200 mg once‐daily doses for 12 weeks (maintenance period). Pooled efficacy variable was standardized (/4 weeks) seizure frequency (SSF) analyzed over the maintenance period as reduction in absolute and relative SSF and proportion of responders (≥50% reduction in SSF). Pooled safety was analyzed by means of adverse events and clinical laboratory assessments. Results SSF was significantly reduced with ESL 800 mg (P