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A MULTICENTER, OPEN-LABEL, RANDOMIZED, ACTIVE COMPARATOR STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF LACOSAMIDE IN NEONATES WITH REPEATED ELECTROENCEPHALOGRAPHIC NEONATAL SEIZURES
Study of lacosamide in neonatal seizures
What is the goal of the study?
SP0968 is a Phase 2/3, multicenter, open-label, randomized, active comparator study to evaluate the efficacy, safety, and PK of LCM in neonates with repeated ENS compared with an Active Comparator chosen based on StOC per the local practice and treatment guidelines.
Who can participate in the study?
Everyone