Status:
TERMINATED
A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Electroencephalographic Neonatal Seizures
Eligibility:
All Genders
1-28 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatmen...
Eligibility Criteria
Inclusion
- 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 CGA 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
Exclusion
- 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
Key Trial Info
Start Date :
May 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03325439
Start Date
May 7 2019
End Date
May 29 2021
Last Update
April 8 2024
Active Locations (12)
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1
N01349 204
Leuven, Belgium
2
N01349 205
Prague, Czechia
3
N01349 207
Lille, France
4
N01349 206
Paris, France