Participant Age Range
neonates (up to 28 days of postnatal age)
“A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures”
Seizures occur more often during the neonatal period than at any other time during life. Due to growing evidence that neonatal seizures contribute to an adverse neurodevelopmental outcome, physicians are increasingly focused on the diagnosis and treatment of this condition. The current available data from randomized, controlled studies to support the choice of anti-epileptic drug (AED) for this indication are limited, and there are currently no definite recommendations on the most suitable treatment. Thus, there is a need to investigate which AEDs should be used to treat neonatal seizures and their most appropriate dosages. Furthermore, although newer AEDs are efficacious for the treatment of seizures in adults and older children, limited progress has been made in the treatment of neonatal seizures. Therefore, clinical studies to assess the efficacy and safety of new treatment options in neonates are warranted. This is a multicenter, open-label, randomized, active comparator study to evaluate the efficacy, safety, and pharmacokinetics of lacosamide in neonates with repeated electroencephalographic neonatal seizures.