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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
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Address
Via Nicolo Putignani 178
70122 Bari
Italy
Activity type
Research Organisations
EU contribution
€ 1 224 676,25
Administrative Contact
Donato Bonifazi (Mr.)

Participants (15)

DOMPE SPA

Participation ended

Italy
Address
Via Campo Di Pile
67100 L'aquila
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cinzia D'ettore (Dr.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 438 138,50
Address
Dr Molewaterplein 40
3015 GD Rotterdam
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
€ 367 088,75
Address
Corso Stati Uniti 4
35127 Padova
Activity type
Research Organisations
Administrative Contact
Luigi Comacchio (Mr.)
SOCIETA SERVIZI TELEMATICI SRL
Italy
EU contribution
€ 359 000
Address
Via Giacomo Medici
35138 Padova
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
€ 136 690,50
Address
Piazza Giulio Cesare 11
70124 Bari
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Domenica Lippolis (Dr.)
PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRLIN SRL
Italy
EU contribution
€ 647 200
Address
Via Einstein Snc
26900 Lodi Lo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Laura Mangiarini (Dr.)
SIHTASUTUS TARTU ULIKOOLI KLIINIKUM
Estonia
EU contribution
€ 156 540,50
Address
Puusepa 1A
50406 Tartu
Activity type
Research Organisations
Administrative Contact
Inga Talvik (Dr.)
DOMPE FARMACEUTICI SPA
Italy
EU contribution
€ 713 500
Address
Via S Martino Della Battaglia 12
20122 Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cinzia D'ettore (Dr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 260 300
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kamilla Kolasinska (Ms.)
UNIVERSITATSKLINIKUM ERLANGEN
Germany
EU contribution
€ 181 918
Address
Maximiliansplatz 2
91054 Erlangen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Katrin Faber (Dr.)
QENDRES SPITALORE UNIVERSITARE NENETEREZA TIRANE
Albania
EU contribution
€ 164 455
Address
Rr Dibres 370
1001 Tirana
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dollani Mirjel (Dr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 450 320,50
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Alix Pillot (Ms.)
CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION
Spain
EU contribution
€ 49 000
Address
Plaza Pablo Picasso 9 3 D
46015 Valencia
Activity type
Other
Administrative Contact
Patricia Brouwer (Dr.)
ISTITUTO GIANNINA GASLINI
Italy
EU contribution
€ 148 791,25
Address
Via Gerolamo Gaslini 5
16147 Genova
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
€ 179 255,75
Address
Thivon And Papadiamantopoulou 1
115 27 Athina
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Eleana Garini (Dr.)