A study to test the pharmacokinetics, efficacy, and safety of brivaracetam in newborns with repeated electroencephalographic seizures.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

- Confirmation on video-electroencephalography (VEEG) of >= 2 minutes of cumulative electroencephalographic neonatal seizures (ENS), or >=3 identifiable ENS prior to entering the Evaluation Period, despite receiving previous antiepileptic drug treatment for the treatment of electroencephalographic seizures. The occurrence of ENS during an up to 1-hour period must be confirmed either by the local or central VEEG reader prior to drug administration. Preferably, the central VEEG reader should confirm the required ENS.
- Subject is male or female and must be at least 34 weeks of corrected gestational age (CGA). In Addition, term neonates up to 27 days of postnatal age (PNA) and preterm neonates up to 40 weeks of postmenstrual age (PMA) and 27 days of PNA can be enrolled
- Subject weighs at least 2.3 kg at the time of enrollment
- Subjects with or without concomitant hypothermia treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 42
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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