SYSTEMATIC REVIEW Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis Simona Lattanzi 1 • Francesco Brigo 2,3 • Elisabetta Grillo 4 • Claudia Cagnetti 1 • Alberto Verrotti 5 • Gaetano Zaccara 6 • Mauro Silvestrini 1 Ó Springer International Publishing AG, part of Springer Nature 2018 Abstract Background In the treatment of pediatric epilepsy, there is a critical demand for effective and safe therapeutic options to address patients’ unmet clinical needs. Eslicarbazepine acetate is a novel once-daily antiepileptic drug and a third- generation single enantiomer member of the dibenzazepine family. Objective The objective of this study was to evaluate the efficacy and safety of eslicarbazepine acetate as add-on treatment for focal-onset seizures in pediatric patients using meta-analytical techniques. Methods Randomized, placebo-controlled, single- or dou- ble-blinded add-on trials of eslicarbazepine acetate in patients \ 18 years of age with focal-onset seizures uncontrolled by concomitant stable antiepileptic drug reg- imens were identified through a systematic literature search. The assessed outcomes included the mean relative change and C 50% reduction in the baseline seizure fre- quency, the incidence of treatment withdrawal, serious adverse events, and treatment-emergent adverse events. Risk ratio and weighted mean difference with 95% confi- dence intervals were estimated for dichotomous/continuous outcomes. Results Two trials were included involving 386 partici- pants (age range 2–18 years), 217 for eslicarbazepine acetate and 169 for placebo groups, respectively. At the dosage of 30 mg/kg/day, eslicarbazepine acetate-treated patients had a significantly greater reduction in baseline seizure frequency (weighted mean difference - 21.67, 95% confidence interval - 40.87 to - 2.46; p = 0.027) and 58 patients (44.6%) were seizure responders compared with 27 controls (29.7%) [risk ratio 1.48, 95% confidence interval 0.99–2.20; p = 0.055]. There were no differences in treatment withdrawal (risk ratio 1.24, 95% confidence interval 0.65–2.37; p = 0.513), serious adverse events (risk ratio 1.40, 95% confidence interval 0.69–2.86; p = 0.350), and treatment-emergent adverse events (risk ratio 1.07, 95% confidence interval 0.94–1.22; p = 0.313). Conclusions Adjunctive eslicarbazepine acetate could be an effective well-tolerated option in children and adoles- cents with focal-onset seizures uncontrolled by one or more concomitant anti-epileptic drugs. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40263-018-0504-x) contains supple- mentary material, which is available to authorized users. & Simona Lattanzi alfierelattanzisimona@gmail.com 1 Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, Ancona 60020, Italy 2 Department of Neuroscience, Biomedicine and Movement Science, University of Verona, Verona, Italy 3 Division of Neurology, ‘‘Franz Tappeiner’’ Hospital, Merano, BZ, Italy 4 Medical Department Eisai s.r.l., San Donato Milanese, Italy 5 Department of Pediatrics, University of L’Aquila, L’Aquila, Italy 6 Unit of Neurology, Department of Medicine, USL Centro Toscana Health Authority, Firenze, Italy CNS Drugs https://doi.org/10.1007/s40263-018-0504-x