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GAbapentin in Paediatric Pain

Objective

Chronic pain is estimated to affect 15-20% of children with varying disabilities. Due to the paucity of clinical information and appropriate medicinal products, in clinical practice paediatric patients are often under-treated causing profound impact on their QoL.
To date, opioids, non-steroid anti-inflammatory drugs (NSAIDs), antidepressants and anticonvulsants are used to treat pain, but only few of these include a paediatric authorisation. In addition, the few available paediatric drugs have a very different authorisation profile across Europe and, when not approved in paediatrics, they are used off-label to cover the high therapeutic need, thus exposing children to unnecessary risks of dosing errors and increasing ADRs.
The GAPP Project is focused on the development of gabapentin for the treatment of paediatric chronic pain, a condition where gabapentin, as demonstrated in adults, is expected to bring great benefit to children.
To this end, a large international scientific Consortium is set up, with experienced professionals in the field of pain that will work together with a Pharmaceutical Company committed to apply for a PUMA using the project results.
Within GAPP, age-appropriate formulation will be developed and two randomised, comparator-controlled clinical trials and a bridging study will be conducted in compliance to a submitted Paediatric Investigation Plan (PIP, Summary Report Day 90 - EMEA-001310-PIP01-12) in order to investigate appropriate dosages, efficacy and safety of gabapentin in the paediatric population. Further to this, in order to ensure the safety of gabapentin in very young children, a non clinical study will be conducted to evaluate the neurotoxic potentil of the drug. At the end of the project, gabapentin can be proposed for treatment of chronic pain in children both as monotherapy and as adjuvant therapy.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Address
Via Nicolo Putignani 178
70122 Bari
Italy

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Activity type
Research Organisations
Administrative Contact
Donato Bonifazi (Mr.)
EU contribution
€ 1 463 082,22

Participants (16)

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 350 181,92
Address
Dr Molewaterplein 40
3015 GD Rotterdam

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ellen Schenk
FONDAZIONE PENTA - FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES - ONLUS
Italy
EU contribution
€ 341 550
Address
Corso Stati Uniti 4
35127 Padova

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Activity type
Research Organisations
Administrative Contact
Silvia Faggion (Dr.)
SOCIETA SERVIZI TELEMATICI SRL
Italy
EU contribution
€ 379 000
Address
Via Giacomo Medici
35138 Padova

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Luigi Cantarutti (Dr.)
AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI
Italy
EU contribution
€ 72 760,47
Address
Piazza Giulio Cesare 11
70124 Bari

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Annunziata Carioggia (Dr.)
PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRL
Italy
EU contribution
€ 1 088 048,57
Address
Via Einstein Snc
26900 Lodi

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mariagrazia Felisi (Dr.)
SIHTASUTUS TARTU ULIKOOLI KLIINIKUM

Participation ended

Estonia
EU contribution
€ 4 119,47
Address
Puusepa 1a
50406 Tartu

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Activity type
Research Organisations
Administrative Contact
Inga Talvik (Dr.)
DOMPE FARMACEUTICI SPA
Italy
EU contribution
€ 600 000
Address
Via S Martino Della Battaglia 12
20122 Milano

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cinzia D'ettore (Dr.)
DOMPE SPA

Participation ended

Italy
Address
Via Campo Di Pile
67100 L'aquila

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cinzia D'ettore (Dr.)
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 286 050
Address
Gower Street
WC1E 6BT London

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Higher or Secondary Education Establishments
Administrative Contact
Kamilla Kolasinska (Ms.)
UNIVERSITATSKLINIKUM ERLANGEN
Germany
EU contribution
€ 173 921,42
Address
Maximiliansplatz 2
91054 Erlangen

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Higher or Secondary Education Establishments
Administrative Contact
Katrin Faber (Dr.)
QENDER SPITALORE UNIVERSITARE NENEA TIRANE
Albania
EU contribution
€ 129 686,42
Address
Rr Dibres 370
1001 Tirana

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dollani Mirjel (Dr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 295 789,92
Address
3 Avenue Victoria
75000 Paris

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Activity type
Research Organisations
Administrative Contact
Alix Pillot (Ms.)
CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION

Participation ended

Spain
Address
Plaza Pablo Picasso 9 3 D
46015 Valencia

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Activity type
Other
Administrative Contact
Patricia Brouwer (Dr.)
CHILDHOOD CANCER INTERNATIONAL
Netherlands
EU contribution
€ 49 000
Address
Kraijenhoffstraat 137 A
1018 RG Amsterdam

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Activity type
Other
Administrative Contact
Patricia Brouwer (Dr.)
ISTITUTO GIANNINA GASLINI
Italy
EU contribution
€ 85 562,16
Address
Via Gerolamo Gaslini 5
16147 Genova

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Maria Gabriella Marinari (Mrs.)
GENIKO NOSOKOMEIO PAIDON ΑTHINON I AGIA SOPHIA - PAIDON PENTELIS
Greece
EU contribution
€ 158 122,43
Address
Thivon And Papadiamantopoulou 1
115 27 Athina

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Eleana Garini (Dr.)