Abstracts

Rationale: In acute seizure emergencies patients require intravenous (IV) medications administered rapidly. Although, the number of anti-epileptic drugs (AED) available has increased in recent years, there continues to be only a limited number of drugs available for IV administration. Lacosamide is the newest AED available with an IV preparation. In prospective studies, lacosamide has been demonstrated to be safe in adults with epilepsy and healthy individuals. The purpose of this study is to evaluate the safety of rapid administration of IV lacosamide in children and young adults with epilepsy.Methods: IRB and FDA (IND) approval was attained and a prospective single-center study was performed in individuals age 4 to 35 years to evaluate the safety of rapid IV administration. A dose escalation protocol was instituted with Group 1 receiving a dose of 0.7 mg/kg (max 50mg), Group 2 receiving 1.4mg/kg (max 100mg), Group 3 receiving 2.1 mg/kg (max 150mg) and Group 4 receiving 2.9 mg/kg (max 200mg). A safety board reviewed the hemodynamic and cardiac (EKG) parameters from each group, before the next group was enrolled. Infusions were given over 30 minutes with vital signs and EKG monitoring at 5, 10, 30, 60, and 120 minutes after initiation. Adverse events were recorded for 12 hours following the infusion. A lacosamide level was obtained 1 to 2 minutes after completion of the infusion.Results: To date 20 patients with ages ranging from 6 to 26 have been enrolled. Doses of lacosamide have ranged from 30 to 200mg. Five patients have received 0.7mg/kg (max 50mg), 5 patients have received 1.4 mg/kg (max 100mg), 5 patients have received 2.1mg/kg (max 150mg), and 5 patients have received 2.9mg/kg (max 200mg). None of the patients have experienced peripheral injection site or symptomatic complications. There also have been no significant peripheral adverse events or hemodynamic or cardiac changes noted. Levels following infusion ranged from 1 to 4.2 mcg/ml.Conclusions: This study demonstrates that lacosamide can be safely administered as a rapid infusion to pediatric patients at doses ranging from 0.7 to 2.9 mg/kg without adverse events, cardiac or hemodynamic changes. These findings will allow the use of IV lacosamide in patients age 4 to 35 years who require rapid administartion of IV lacosamide in emergency situations. Research funded by The Shainberg Neuroscience Research Fund.