DISCUSSION
critically ill, epilepsy
CRITICALLY ILL, EPILEPSY
This open‐label, multicentre trial is the largest prospective investigation of the safety and tolerability of IV lacosamide in pediatric patients with epilepsy. IV lacosamide (2–12 mg/kg/day or 100‐600 mg/day) was generally well tolerated in patients ≥1 month to <17 years of age, and no new safety concerns were identified. Nearly 72% of patients had not received lacosamide treatment in the 3 months preceding the trial, and most of the remaining patients were receiving oral lacosamide from a commercial supply. There was a mean overall exposure of IV lacosamide of 1.18 days, and most patients received one dose as a 30‐ to 60‐minute infusion.Bioequivalence of IV and oral lacosamide has been established in adults.As has been previously observed in studies of IV lacosamide in pediatric patients with epilepsy and in critically ill children, TEAEs were reported in few patients.The design of this trial was intended to maximize the available pool of patients by allowing for entry of individuals who were receiving oral lacosamide as adjunctive treatment or monotherapy (in an open‐label long‐term trial or by prescription), in addition to those who initiated IV lacosamide as adjunctive treatment following enrolment. Patients with ongoing oral lacosamide treatment were on a stable dose.