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Summary   Objective  To assess the efficacy and safety of eslicarbazepine acetate ( ESL ) as monotherapy in North American patients with partial‐onset seizures ( POS ).    Methods  This multicenter, randomized, double‐blind “withdrawal to monotherapy” study used historical control data as the comparator. Adults with  POS  medically uncontrolled by one to two antiepileptic drugs gradually converted to  ESL  monotherapy. Following an 8‐week baseline period, patients were randomized 2:1 to receive  ESL  1,600 mg (n = 128) or 1,200 mg  QD  (n = 65) for 18 weeks. The primary end point was the proportion of patients meeting predefined exit criteria (signifying worsening seizure control). Treatment was considered effective if the 95% upper confidence limit ( UCL ) for the Kaplan‐Meier estimated exit rate was lower than the exit rate threshold calculated from the historical control (65.3%).    Results  Kaplan‐Meier estimated exit rates were:  ESL  1,600 mg, 28.7% (95%  CI  21.2–38.1%) and 1,200 mg, 44.4% (32.5–58.3%). The difference between doses was not significant (p = 0.07). For both doses, the 95%  UCL s for the exit rate were ˂65.3%;  ESL  monotherapy was considered superior to the historical control. There was no statistically significant increase in the risk of study exit related to carbamazepine use. Nine (7.6%) and five patients (8.3%) remained seizure‐free during the 10‐week monotherapy period, while taking  ESL  1,600 and 1,200 mg, respectively. The reductions in median standardized seizure frequency (seizures per 28 days) between baseline and the 18‐week treatment period were:  ESL  1,600 mg, 42% and 1,200 mg, 31%. Treatment‐emergent adverse events ( TEAE s) occurring in ≥10% of patients were dizziness, headache, fatigue, somnolence, nausea, and nasopharyngitis. The  TEAE  most frequently leading to discontinuation was hyponatremia (2.1%).    Significance   ESL  was efficacious and well tolerated as monotherapy in North American patients, and led to a reduction in seizure frequency. Exit rates for  ESL  1,600 and 1,200 mg  QD  were superior to the historical control; the difference in exit rates between doses was not statistically significant.

epilepsia

Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial‐onset seizures: A randomized historical‐control phase  III  study based in North America