Limitations
epilepsy
FOCAL SEIZURES, CLONIC SEIZURES, EPILEPSY
This trial is limited by its open‐label, uncontrolled design with no comparator or placebo group. The patient population was mostly White; the results may not be generalizable across racial groups. However, no relevant differences in the pharmacokinetics of lacosamide have been observed between healthy Asian, Black, and Caucasian individuals.Overall, IV lacosamide had an acceptable tolerability profile in pediatric patients ≥1 month to <17 years of age with epilepsy and focal seizures or primary generalized tonic–clonic seizures. No new safety concerns were identified.