A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

Inclusion Criteria:

• Participant must be ≥34 weeks of corrected gestational age (CGA), <46 weeks of CGA,and <28 days of postnatal age (PNA)

• Participants who have confirmation on video-electroencephalogram (EEG) of ≥2 minutesof cumulative electroencephalographic neonatal seizures (ENS) or ≥3 identifiable ENSprior to entering the Treatment Period

• Participants must have received either phenobarbital (PB), levetiracetam (LEV), ormidazolam (MDZ) (in any combination) before entering the study

• Participant weighs at least 2.3 kg at the time of enrollment Informed consent

• An Independent Ethics Committee (IEC)-approved written informed consent form (ICF)is signed and dated by the participant's parent(s) or legal representative(s)

Exclusion Criteria:

• Participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which atargeted, known treatment is available

• Participant has seizures related to prenatal maternal drug use or drug withdrawal

• Participant has a clinically relevant electrocardiogram (ECG) abnormality, in theopinion of the investigator

• Participant receiving treatment with phenytoin (PHT), lidocaine (LDC), or othersodium channel blockers at any time