NEMO
Treatment of NEonatal seizures with Medication Off-patent: evaluation of efficacy and safety of bumetanide
| Coordinatore | UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
| Nazionalità Coordinatore | United Kingdom [UK] |
| Sito del progetto | http://www.nemo-europe.com/ |
| Totale costo | 7˙020˙774 € |
| EC contributo | 5˙370˙802 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2009-single-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2009 |
| Periodo (anno-mese-giorno) | 2009-10-01 - 2015-03-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
UK (LONDON) | coordinator | 926˙970.00 |
| 2 |
UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK
Organization address
address: Western Road contact info |
IE (CORK) | participant | 1˙212˙648.00 |
| 3 |
Only For Children Pharmaceuticals
Organization address
address: Rue Henri Barbusse 35 bis contact info |
FR (Paris) | participant | 742˙214.06 |
| 4 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | participant | 565˙685.00 |
| 5 |
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O
Organization address
address: Oskar-von-Miller-Ring 29 contact info |
DE (MUENCHEN) | participant | 367˙800.00 |
| 6 |
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Organization address
address: HEIDELBERGLAAN 100 contact info |
NL (UTRECHT) | participant | 307˙362.00 |
| 7 |
Nome Ente NON disponibile
Organization address
address: STENBACKINKATU 9 contact info |
FI (HELSINKI) | participant | 228˙409.00 |
| 8 |
UPPSALA UNIVERSITET
Organization address
address: SANKT OLOFSGATAN 10 B contact info |
SE (UPPSALA) | participant | 191˙220.00 |
| 9 |
UNIVERSITY OF LEEDS
Organization address
address: WOODHOUSE LANE contact info |
UK (LEEDS) | participant | 183˙072.00 |
| 10 |
KAROLINSKA INSTITUTET
Organization address
address: Nobels Vag 5 contact info |
SE (STOCKHOLM) | participant | 164˙040.00 |
| 11 |
Great Ormond Street Hospital for Children NHS Trust
Organization address
address: Great Omond Street contact info |
UK (LONDON) | participant | 140˙103.60 |
| 12 |
DUKE UNIVERSITY
Organization address
address: BLACKWELL ST SUITE 920 324 contact info |
US (DURHAM) | participant | 108˙160.00 |
| 13 |
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
NL (ROTTERDAM) | participant | 81˙689.00 |
| 14 |
CLININFO S.A.
Organization address
address: RUE DE GERLAND- ENTREE 7 99 contact info |
FR (LYON) | participant | 76˙575.00 |
| 15 |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Organization address
address: 3 Avenue Victoria contact info |
FR (PARIS) | participant | 74˙855.00 |
Mappa
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Obiettivo del progetto (Objective)
'Neonatal hypoxic ischaemic encephalopathy (HIE) occurs in 2-3/1000 live births and is a major cause of both acute mortality and long-term neurodisability. Seizures are the hallmark of HIE. The clinical and electrographic seizure burden in babies with HIE can be considerable and is often not reduced by current antiepileptic drugs. Phenobarbitone remains the first line drug for neonatal seizures despite the fact that it has limited efficacy. Better treatments for neonatal seizures, particularly in asphyxiated babies, are a high research priority with the ultimate aim to improve long-term outcome.
The aim of NEMO is to develop an effective treatment regimen for neonatal seizures using innovative strategies, targeted specifically to the needs and peculiarities of babies. An age dependent high expression of neuronal co-transporter resulting in excitatory rather than inhibitory function of GABA is believed to be responsible for the high incidence of seizures in the neonatal period. By blocking this co-transporter with bumetanide, a loop diuretic, the depolarizing action of GABA will be reversed resulting in reduced neuronal firing. Intensive EEG monitoring will enable us to accurately identify seizures and monitor treatment effect. A European-wide multicentre approach would, for the first time facilitate performing an RCT with enough statistical power in this age-group.
By consolidating efforts from basic science, pharmacology and clinical centres we propose: 1. to perform a European-wide, multicentre, randomised, placebo-controlled, double-blind trial to evaluate the efficacy and safety of bumetanide in neonates 2. to perform pharmacokinetic and pharmacodynamic studies of bumetanide 3. to further investigate the mechanisms of action in non-clinical experiments 4. to develop and adapt a bumetanide formulation suitable for neonates in order to apply for a Paediatric Use Marketing Authorization (PUMA). 5. if results of the initial trial do not support a PUMA application we plan to apply for a Paediatric Investigation Plan (PIP) for lidoocaine to assess its efficacy as an AED for the control of seizures which are not controlled by phenobarbitone.'
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