Phase 2/3 study in neonates with repeated EEG seizures
Research type
Research Study
Full title
A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
IRAS ID
217211
Contact name
Ronit Pressler
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2015-002756-27
Duration of Study in the UK
2 years, 0 months, 25 days
Research summary
Acute seizures are the most common neurological emergency in newborn babies, arising in roughly 3/ 1000 term live births and are associated with significant mortality and neuro-developmental disability. Neonatal seizures are a major challenge for clinicians because of inconspicuous clinical presentation, variable electro-clinical correlation and poor response to antiepileptic drugs. There is an urgent need for the development of effective and safe antiepileptic drugs for infants.\nThe current accepted medical practice (i.e., standard of care) for neonatal seizures is initial treatment with phenobarbital (PB). Second line treatments not standardised, with a variety of drugs used including midazolam, levetiracetam, phenytoin, lidocain, and others. In the UK its usually midazolam\n\nN01349 represents the first study of brivaracetam (BRV) in neonatal participants, and will evaluate the pharmacokinetics, efficacy, and safety of BRV in neonates (with an age at birth of 34 weeks to less than 42 weeks of gestational age (GA) and up to 28 days of postnatal age) with repeated EEG seizures. A historical control group treated with midazolam from literature (matched in age and condition) will be used for the evaluation of efficacy.\n\nAs the patient population of neonates with ENS is limited, the 2-step design of this study will allow confirmation (or adjustment) of dosing based on results from the first step (Exploratory Cohort) and evaluation of brivaracetam efficacy in the second step (Confirmatory Cohorts).\n\nAll participants who participate in the BRV Extension Period will be offered entry into the long-term study N01266, if they meet the eligibility criteria. \n\nBrivaracetam, both oral and intravenous solutions, will be supplied by the study Sponsor, UCB Biopharma SPRL. Commercial MDZ and PB will be used for this study and will not be provided by the Sponsor.\n\nIn this study, about 16 hospitals and approximately 42 patients will participate. The maximum study duration per participant will be up to 75 days (Screening Period, Baseline Period, Evaluation Period, BRV Extension Period, Down-Titration Period, and Safety Follow-Up Period).
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0727
Date of REC Opinion
2 Aug 2017
REC opinion
Further Information Favourable Opinion