Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – An open-label trial

•Open-label fixed-titration trial of lacosamide in children aged 6 month–≤17 years.•Adjunctive lacosamide ≤12 mg/kg/day was generally well tolerated in children.•Lacosamide safety profile in children was generally consistent with that seen in adults.•No observed relationship between lacosamide dose and incidence of specific TEAEs. To evaluate safety and tolerability of adjunctive lacosamide in children with focal seizures. Patients were eligible for this open-label, fixed-titration trial (SP0847; NCT00938431) if aged 1 month–17 years with focal seizures taking 1–3 antiepileptic drugs. Findings from Cohort 1, aged 5–11 years, who received lacosamide ≤8 mg/kg/day, informed dosing for age-based cohorts 2–5, who then received ≤12 mg/kg/day (≤600 mg/day). Oral lacosamide was initiated at 2 mg/kg/day (1 mg/kg bid) and uptitrated by 2 mg/kg/day/week to the maximum cohort-defined dose (maximum trial duration: 13 weeks). Patients who did not achieve the maximum cohort-defined dose were discontinued. Forty-seven patients (aged 6 months–≤17 years) enrolled (≥1 month–