Abstract
ObjectiveIn Europe, eslicarbazepine acetate (ESL) is approved as adjunctive therapy for the treatment of focal seizures (FS) in children aged >6 years. In the US, ESL is approved as both monotherapy and adjunctive therapy for the treatment of FS in patients aged ≥4 years. In a phase II study of children aged 6–16 years with FS, ESL had no significant effects on attention or behavioral functioning and decreased seizure frequency during double-blind therapy and a 1-year open-label extension (OLE). This report presents data from an additional 2-year OLE of the phase II study. MethodsPrevious recipients of ESL or placebo were treated with open-label ESL (10–30 mg/kg/day, adjusted for clinical response and/or adverse events [AEs]). Safety was assessed by incidence of treatment-emergent AEs (TEAEs). Efficacy endpoints were treatment retention time and change from baseline in Clinical Global Impression-Severity (CGI-S) scale scores. ResultsForty-two patients entered and 31 (73.8%) completed the 2-year OLE. Median treatment retention time was 735 (95% confidence interval 728–741) days. Seven patients (17% of total, 23% of completed) experienced ≥1 TEAE during the 2-year OLE, mostly of mild or moderate intensity. The incidence of serious TEAEs was low (n = 2; 5% of total, 6% of completed) and none were related to ESL. One child was withdrawn because of splenomegaly that was considered possibly related to ESL. The only change from baseline in CGI-S was a 0.5-point reduction in the severity of illness score. All findings were consistent across patient subgroups based on previous double-blind treatment (placebo or ESL) and patient age (6–11 or 12–16 years). ConclusionsThe majority of patients remained on ESL during the 2-year OLE, and treatment efficacy was maintained. Adverse events were consistent with the known safety profile of ESL, and no new safety signals were identified.
Highlights
Eslicarbazepine acetate (ESL) is a central nervous system (CNS)active compound that belongs to the dibenz[b,f]azepine family of antiseizure medications (ASMs), [1]
There is evidence that ESL enhances the slow inactivation of voltage-gated sodium channel (VGSC), which may dampen neuronal excitability [4]
Eslicarbazepine acetate is approved in the European Union as monotherapy for the treatment of focal seizures (FS), with or without secondary generalization, in adults with newly diagnosed epilepsy, and as adjunctive therapy in adults, adolescents and children aged >6 years with focal seizures (FS), with or without secondary generalization [8]
Summary
In Europe, eslicarbazepine acetate (ESL) is approved as adjunctive therapy for the treatment of focal seizures (FS) in children aged >6 years. In the US, ESL is approved as both monotherapy and adjunctive therapy for the treatment of FS in patients aged 4 years. In a phase II study of children aged 6– 16 years with FS, ESL had no significant effects on attention or behavioral functioning and decreased seizure frequency during double-blind therapy and a 1-year open-label extension (OLE). Efficacy endpoints were treatment retention time and change from baseline in Clinical Global Impression-Severity (CGI-S) scale scores. Seven patients (17% of total, 23% of completed) experienced 1 TEAE during the 2-year OLE, mostly of mild or moderate intensity. All findings were consistent across patient subgroups based on previous double-blind treatment (placebo or ESL) and patient age (6–11 or 12–16 years).
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