To evaluate the occurrence of psychiatric treatment-emergent adverse events (TEAEs) and suicidality in clinical trials of eslicarbazepine acetate (ESL) for focal (partial-onset) seizures in children.

ESL is a once-daily oral antiepileptic drug (AED) for focal seizures. Psychiatric and/or suicidality-related TEAEs have been associated with AED treatment, and some were observed during clinical trials of ESL in adults.

This post-hoc analysis evaluated safety and tolerability data pooled from two randomized, double-blind, placebo-controlled trials (BIA-2093-208 and -305) of adjunctive ESL treatment in pediatric patients (4–17 years) with refractory focal seizures. In Study 208-Part 1, patients (6–16 years) received ESL (target dose 30 mg/kg/day) for 12 weeks. In Study 305-Part 1, patients (2–18 years) received ESL (target dose 20 mg/kg/day) for 18 weeks. All patients could continue into uncontrolled, open-label extension (OLE) studies of ESL. We evaluated psychiatric disorder TEAEs, serious adverse events (SAEs), TEAEs leading to discontinuation, and suicidal-ideation/behavior events.

Psychiatric TEAEs were uncommon, and there were no reports of suicidal ideation or behavior during double-blind and OLE studies of adjunctive ESL in children (aged 4–17 years) with focal seizures.