Academic Lead: Dr. Ronit Pressler (UCL)
WP partners: UCC, O4CP, INSERM, HUS, UNIVLEEDS, UU, UMCU, AP-HP, KI, GOSHFCNT, EMC
NEMO1: dose finding, feasibility and pharmacokinetic study
NEMO2: randomised, placebo-controlled, double-blind clinical
Two clinical trials are planned:
NEMO 1 - phase I/IIa: dose finding, feasibility and pharmacokinetic study of bumetanide for the treatment of neonatal seizures not responding to phenobarbitone with the aim to estimate the optimal dose of bumetanide as an antiepileptic drug in neonatal seizures.
NEMO 2 - phase IIb/III, randomised, placebo-controlled, double-blind, clinical trial to evaluate the efficacy and safety of the optimal dose of bumetanide for treatment of neonatal seizures not responding to phenobarbitone.
The aim of this work package is to perform the two clinical trails of NEMO iwith the aim to evaluate the efficacy and safety of bumetanide for treatment of neonatal seizures not responding to phenobarbitone. The results will provide detailed information relating to the safety and efficacy of bumetanide in the newborn which is required for a PUMA application (WP 10). This pivotal trial will need to take account of information required for regulatory processes and the particular issues relating to trials of antiepileptic drug in newborn infants with seizures.
These studies will be the largest multicenter European studies of neonatal seizures and their treatment to date. The trials will be conducted according to the highest ethical standards and following Good Clinical Practice (GCP) in European accredited centres. Together with WP 05, WP 10 and WP 11 we will ensure that the rights, safety and well-being of enrolled babies are the most important consideration of everybody involved in the study.
EEG monitoring is considered to be the gold standard for seizure diagnosis and treatment monitoring. The study will use continuous EEG for diagnosis and monitoring in all enrolled newborns (simultaneous video monitoring will also be used if available). This will enable accurate seizure detection during the clinical trial which is the primary outcome measure.
The responsibilities and duties of WP 04 during the clinical trials are:
Several tasks in the clinical trials are the responsibility of the local principal investigators and scientific leads. We will support local trial centres in these activities: