WP lead: Dr. Ronit Pressler (UCL)
WP partners: UCC, O4CP, INSERM, HUS, UNIVLEEDS, UU, UMCU, AP-HP, KI, GOSHFCNT, EMC
It is the objective of this work package to develop an effective management framework to facilitate the clinical trials of NEMO. This includes managerial and administrative tasks at a central level as well as coordination and facilitation at individual centres including compliance with GCP (good clinical practice) as well as safety, legal and ethical issues. This will ensure the correct progress of the project towards its planned objectives.
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, randomized, 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.
Both trials will be conducted by highly specialised centres from five different European countries requiring a detailed framework which will be set up during the first 6-9 months. This is the main task of WP 01 in close relationship with the sponsors of the trial (GOSH-FCNT and O4CP), other WP partners (UCC, INSERM, HUS, AP-HP) and the principal investigators of the clinical trial.
WP 01 will set up a trial management group and appoint clinical trial experts. Furthermore, setting up of the relevant independent advisory groups will be facilitated in accordance with the project milestones such as ethics advisory group (WP 05), clinical development management unit (WP 11) and the data and safety monitoring committee (WP 05).
Tasks of WP 01:
Several tasks in the setup are the responsibility of the local principal investigators and scientific leads. We will support local trial centres in these activities:
GCP training of all clinical trial staff involved in the trial.