A study to test the pharmacokinetics, efficacy, and safety of brivaracetam in newborns with repeated electroencephalographic seizures.
- Conditions
- Electroencephalographic neonatal seizuresTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-002756-27-NL
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
- Confirmation on video-electroencephalography (VEEG) of >= 2 minutes
of cumulative
electroencephalographic neonatal seizures (ENS), or >=3 identifiable
ENS within the 2 hours prior to
entering the Evaluation Period, despite receiving phenobarbital (PB) for
the treatment of repeated seizures
- Subject is male or female with an age at birth of at 34 weeks to less
than 42 of gestational age (GA) and up to 28 days of postnatal age at the
time of enrollment
- 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
Subject received antiepileptic drug (AED) treatment (other than the required 1 or 2 doses of
phenobarbital (PB) [total therapeutic administered dose of 20 to 40mg/kg] for the treatment of repeated
seizures) prior to entering the Evaluation Period.
- Subject with seizures responding to PB (total therapeutic administered dose of 20 to 40mg/kg),
pyridoxine treatment, or correction of metabolic disturbances (hypoglycemia, hypomagnesemia or
hypocalcemia)
- 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), according to the subject’s gestational
age (GA) and the site’s normal range values for the respective GA
- Subject has conjugated bilirubin levels >2mg/dL
- 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
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