Epilepsy affects the pediatric population with an estimated prevalence of 6.8 per 1,000 insured children. Newly introduced antiepileptic drugs (AEDs) may be used off-label in children with epilepsy before completion of pediatric regulatory studies, creating an opportunity to evaluate the real-world use and safety of these drugs in children to support the pediatric clinical trial program.
Vimpat® (lacosamide, LCM) is an AED that selectively enhances the slow inactivation of voltage-gated sodium channels without affecting rapid inactivation. It is available as oral solution, oral tablet, and intravenous (IV) solution. It is currently approved in USA for use as oral solution, oral tablet in patients over 4 years of age and as IV solution in patients over 16 years of age as an alternative to oral administration. Vimpat® was approved on October 2008 and first introduced to the market in 2009. IV use of lacosamide in children over four years is however authorized in the EU; its benefit risk profile is assessed as favorable by UCB and by the EU Health Authorities. Vimpat® injection is only indicated in USA for the treatment of partial-onset seizures in adults (17 years of age and older). Vimpat® dosage in adult patients can be started with the recommended initial dosage (as monotherapy 100 mg twice daily; as adjunctive therapy 50 mg twice daily) followed by a titration regimen (increase by 50 mg twice daily every week). Alternatively, it may be initiated with a single loading dose of 200 mg. The use of a loading dose in pediatric patients has not been studied yet. The purpose of the present study is to characterize further the safety of IV LCM in a pediatric population by using available data from electronic healthcare databases.