Lacosamide dosing
epilepsy
EPILEPSY
The trial consisted of a screening and/or baseline period of up to 7 days; a treatment period; a final visit (1 day); and a safety follow‐up via telephone over a period of 1‐3 days. Patients received IV lacosamide based on clinical need or elective administration. Clinical need administration applied to patients who needed to undergo a procedure and were being treated at an epilepsy monitoring unit or healthcare facility or were in other situations where IV administration was clinically appropriate and oral administration was not feasible (e.g., surgery). For these patients, the maximum number of IV lacosamide doses was 10 (administered twice daily with an interval of approximately 12 hours, over a duration of ≤5 days). Elective administration applied to patients who were taking oral lacosamide (or any enteric lacosamide administration, e.g., by feeding tube), and elected to receive IV lacosamide at an epilepsy monitoring unit or healthcare facility. For these patients, a maximum of two IV lacosamide doses were permitted (over approximately 24 hours). Patients who only required one IV lacosamide infusion could complete all the trial periods in 1 day, provided there was sufficient time for all examinations and the final visit assessments.Patients receiving lacosamide before this trial received IV lacosamide (as adjunctive treatment or monotherapy) as a replacement for oral lacosamide in a twice‐daily regimen at the same stable daily dose they had been receiving before the present trial: 2‐12 mg/kg/day or 100‐600 mg/day, with a maximum dose of 12 mg/kg/day or 600 mg/day, whichever was lower. Patients initiating lacosamide received IV lacosamide as adjunctive treatment only (initiation of IV lacosamide monotherapy was not permitted) in a twice‐daily regimen at a dose of 2 mg/kg/day for patients weighing <50 kg, and 100 mg/day for patients weighing ≥50 kg (the dose was to remain unchanged for the duration of the treatment period).The first 20 patients enrolled in cohort 1 had a target IV lacosamide infusion duration of 30‐60 minutes. Following IDMC recommendations, the remaining patients in cohort 1 had a target infusion duration of 15‐30 minutes, provided that the investigator considered that they would directly benefit from an increased infusion rate. Patients who would not directly benefit from a faster infusion (in the opinion of the investigator) had a target infusion duration of 30‐60 minutes. For the first 20 patients in cohort 2, IV lacosamide was infused over a target duration of 30‐60 minutes whenever possible. Once these patients had completed the trial, a second IDMC review took place and recommended that a 30‐60 minutes infusion duration should continue to be used in cohort 2, as no previous participants had a clinical need necessitating a dose infusion time of 15‐30 minutes.Patients who entered EP0060 from an open‐label, long‐term trial (SP848 or EP0034) suspended their participation in that trial temporarily to receive IV lacosamide. Upon completion of the EP0060 trial, eligible patients who had received prescribed lacosamide from commercial supply or who were not receiving lacosamide before enrolment had the option to continue oral lacosamide in another open‐label trial (SP848).