A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures

Exclusion Criteria

• •Subjects are not permitted to be enrolled in the study if any of the following criteria are met:
• •Subject receiving antiepileptic drug (AED) treatment other than phenobarbital, midazolam, phenytoin, levetiracetam (≤60 mg/kg/day), or lidocaine for the treatment of seizures prior to or at the time of enrollment (Confirmatory Cohorts only)
• •Subject with seizures responding to any of the following: previous AED treatment immediately prior to BRV treatment, pyridoxine treatment, or correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia)
• •Subject requires extra corporeal membrane oxygenation
• •Subject has seizures related to prenatal maternal drug use or drug withdrawal
• •Subject has known severe disturbance of hemostasis, as assessed by the Investigator
• •Subject has a poor prognosis for survival, as judged by the Investigator
• •Subject has 2x upper limit of normal (ULN) of any of the following: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP), with the following exception:
• •For subjects with perinatal asphyxia, elevation of AST, ALT or ALP \<5x ULN is acceptable, if initial and peak elevation of liver function tests (LFTs) occurs within 5 days after birth, and the time course of LFT elevation is compatible with hepatic injury due to perinatal asphyxia. The determination of ULN will be based on the subject's gestational age (GA) and the site's normal range values for the respective GA
• •Subject has direct (conjugated) bilirubin levels \>2 mg/dL
• •Subject requiring or expected to require phototherapy or exchange transfusion due to elevated bilirubin
• •Subject with rapidly increasing bilirubin that may preclude the subject from inclusion in the study at the discretion of the Investigator