Patient eligibility
epilepsy
APPENDIX, FOCAL SEIZURES, CLONIC SEIZURES, EPILEPSY
Patients could be enrolled if they were ≥1 month to <17 years of age, had a diagnosis of epilepsy with focal seizures or primary generalized tonic–clonic seizures, weighed ≥4 kg, and were considered an acceptable candidate for venipuncture and IV infusion. In addition, eligible patients were (i) receiving oral lacosamide as adjunctive treatment or monotherapy in an open‐label long‐term trial (SP848 or EP0034); (ii) receiving prescribed oral lacosamide from a commercial supply as adjunctive treatment or monotherapy; or (iii) not receiving lacosamide treatment before enrolment (would receive IV lacosamide as a new adjunctive treatment in EP0060).For patients who were receiving lacosamide upon enrolment, oral lacosamide must have been administered at a dose of 2‐12 mg/kg/day (in patients <50 kg) or 100‐600 mg/day (in patients ≥50 kg) for ≥2 weeks before screening. Oral lacosamide dose must have been stable for at least 3 days before the first lacosamide infusion. Patients initiating lacosamide had to be on a stable dosage regimen of at least one ASM, which must have been kept constant for ≥2 weeks before screening, and must not have received lacosamide within the 3 months before screening. Further details of eligibility and withdrawal criteria may be found in Supporting Information (Appendix 