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
city: LONDON
postcode: WC1E 6BT

contact info
Titolo: Ms.
Nome: Greta
Cognome: Borg-Carbott
Email: send email
Telefono: +44 20 3108 3033
Fax: +44 20 3108 3096

 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

# participant  country  role  EC contrib. [€] 
1    UNIVERSITY COLLEGE LONDON

 Organization address address: GOWER STREET
city: LONDON
postcode: WC1E 6BT

contact info
Titolo: Ms.
Nome: Greta
Cognome: Borg-Carbott
Email: send email
Telefono: +44 20 3108 3033
Fax: +44 20 3108 3096

UK (LONDON) coordinator 926˙970.00
2    UNIVERSITY COLLEGE CORK, NATIONAL UNIVERSITY OF IRELAND, CORK

 Organization address address: Western Road
city: CORK
postcode: -

contact info
Titolo: Ms.
Nome: Mary
Cognome: Cusack
Email: send email
Telefono: 353215000000
Fax: 353215000000

IE (CORK) participant 1˙212˙648.00
3    Only For Children Pharmaceuticals

 Organization address address: Rue Henri Barbusse 35 bis
city: Paris
postcode: 75005

contact info
Titolo: Mr.
Nome: Vincent
Cognome: Grek
Email: send email
Telefono: +33 1 75 00 02 87
Fax: +33 1 43 26 18 81

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
city: PARIS
postcode: 75654

contact info
Titolo: Ms.
Nome: Annick
Cognome: Bertault
Email: send email
Telefono: 33140784901
Fax: 33140784997

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
city: MUENCHEN
postcode: 80333

contact info
Titolo: Ms.
Nome: Birgit
Cognome: Fuchs
Email: send email
Telefono: +49 89 288 104 14
Fax: +49 89 288 104 20

DE (MUENCHEN) participant 367˙800.00
6    UNIVERSITAIR MEDISCH CENTRUM UTRECHT

 Organization address address: HEIDELBERGLAAN 100
city: UTRECHT
postcode: 3584 CX

contact info
Titolo: Dr.
Nome: Margot
Cognome: Van Der Starre
Email: send email
Telefono: +31 88 7556422
Fax: +31 88 7555018

NL (UTRECHT) participant 307˙362.00
7    Nome Ente NON disponibile

 Organization address address: STENBACKINKATU 9
city: HELSINKI
postcode: 29

contact info
Titolo: Ms.
Nome: Anne
Cognome: Karikumpu
Email: send email
Telefono: 358947000000
Fax: 358947000000

FI (HELSINKI) participant 228˙409.00
8    UPPSALA UNIVERSITET

 Organization address address: SANKT OLOFSGATAN 10 B
city: UPPSALA
postcode: 751 05

contact info
Titolo: Ms.
Nome: Inga
Cognome: Andersson
Email: send email
Telefono: +46 18 6115920
Fax: +46 18 559775

SE (UPPSALA) participant 191˙220.00
9    UNIVERSITY OF LEEDS

 Organization address address: WOODHOUSE LANE
city: LEEDS
postcode: LS2 9JT

contact info
Titolo: Ms.
Nome: Kathy
Cognome: Brownridge
Email: send email
Telefono: +44 113 343 6050
Fax: +44 113 343 4058

UK (LEEDS) participant 183˙072.00
10    KAROLINSKA INSTITUTET

 Organization address address: Nobels Vag 5
city: STOCKHOLM
postcode: 17177

contact info
Titolo: Mr.
Nome: Rolf
Cognome: Trana
Email: send email
Telefono: +46 8 524 87741
Fax: +46 8 585 822 24

SE (STOCKHOLM) participant 164˙040.00
11    Great Ormond Street Hospital for Children NHS Trust

 Organization address address: Great Omond Street
city: LONDON
postcode: WC1N 3JH

contact info
Titolo: Dr.
Nome: Jo
Cognome: Southern
Email: send email
Telefono: +44 207 905 2179
Fax: +44207 905 2201

UK (LONDON) participant 140˙103.60
12    DUKE UNIVERSITY

 Organization address address: BLACKWELL ST SUITE 920 324
city: DURHAM
postcode: 27701

contact info
Titolo: Ms.
Nome: Oshrat
Cognome: Benmoshe-Doriocourt
Email: send email
Telefono: 19196819712
Fax: +1919 6844595

US (DURHAM) participant 108˙160.00
13    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Dr.
Nome: Sandra
Cognome: Horsch
Email: send email
Telefono: +31 10 7036077
Fax: +31 10 7036811

NL (ROTTERDAM) participant 81˙689.00
14    CLININFO S.A.

 Organization address address: RUE DE GERLAND- ENTREE 7 99
city: LYON
postcode: 69007

contact info
Titolo: Ms.
Nome: Corinne
Cognome: Chevarier
Email: send email
Telefono: +33 478 614 426
Fax: +33 478 583 167

FR (LYON) participant 76˙575.00
15    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

 Organization address address: 3 Avenue Victoria
city: PARIS
postcode: 75004

contact info
Titolo: Mr.
Nome: Christophe
Cognome: Misse
Email: send email
Telefono: 33144841770
Fax: 33144841788

FR (PARIS) participant 74˙855.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

neonatal    ing    bumetanide    multicentre    gaba    paediatric    treatment    clinical    first    trial    efficacy    action    plan    neonates    seizures    age    co    phenobarbitone    babies    hie    puma    neuronal    perform    transporter   

 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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