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Conversion To Eslicarbazepine Acetate Monotherapy: A Pooled Analysis Of 2 Phase Iii Studies., Michael R Sperling, Jacqueline French, Mercedes P Jacobson, Ladislav Pazdera, Mallory Gough, Hailong Cheng, Todd Grinnell, David Blum

Department of Medicine Faculty Papers

OBJECTIVE: To assess the efficacy and safety of eslicarbazepine acetate (ESL) monotherapy.

METHODS: This post hoc pooled analysis of 2 randomized double-blind studies (093-045 and -046) included adults with partial-onset seizures medically uncontrolled by 1 or 2 antiepileptic drugs (AEDs). Following the baseline period (8 weeks), eligible patients were randomized 2:1 to receive ESL 1,600 mg or 1,200 mg once daily for 18 weeks; the primary endpoint was study exit by meeting predefined exit criteria (signifying worsening seizure control). In each study, treatment was considered effective if the upper 95% confidence limit for exit rate was lower than the historical …