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. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesclinical medicinepaediatrics Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2013.4.2-1 - Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulations and/or delivery systems 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 See on map Region Sud Puglia Bari Activity type Research Organisations Administrative Contact Donato Bonifazi (Mr.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 1 463 082,22 Participants (16) Sort alphabetically Sort by EU Contribution Expand all Collapse all ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Netherlands EU contribution € 350 181,92 Address Dr molewaterplein 40 3015 GD Rotterdam See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Ellen Schenk Links Contact the organisation Opens in new window Website Opens in new window FONDAZIONE PENTA ETS Italy EU contribution € 341 550,00 Address Corso stati uniti 4 35127 Padova See on map Region Nord-Est Veneto Padova Activity type Research Organisations Administrative Contact Silvia Faggion (Dr.) Links Contact the organisation Opens in new window Website Opens in new window SOCIETA SERVIZI TELEMATICI SRL Italy EU contribution € 379 000,00 Address Via medici giacomo 9/a 35138 Padova See on map Region Nord-Est Veneto Padova Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Luigi Cantarutti (Dr.) Links Contact the organisation Opens in new window Website Opens in new window AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI Italy EU contribution € 72 760,47 Address Piazza giulio cesare 11 70124 Bari See on map Region Sud Puglia Bari Activity type Higher or Secondary Education Establishments Administrative Contact Annunziata Carioggia (Dr.) Links Contact the organisation Opens in new window PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRL Italy EU contribution € 1 088 048,57 Address Via einstein snc 26900 Lodi See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Mariagrazia Felisi (Dr.) Links Contact the organisation Opens in new window Website Opens in new window SIHTASUTUS TARTU ULIKOOLI KLIINIKUM Participation ended Estonia EU contribution € 4 119,47 Address Puusepa 1a 50406 Tartu See on map Region Eesti Eesti Lõuna-Eesti Activity type Research Organisations Administrative Contact Inga Talvik (Dr.) Links Contact the organisation Opens in new window Website Opens in new window DOMPE FARMACEUTICI SPA Italy EU contribution € 600 000,00 Address Via s martino della battaglia 12 20122 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Cinzia D'ettore (Dr.) Links Contact the organisation Opens in new window Website Opens in new window DOMPE SPA Participation ended Italy EU contribution € 0,00 Address Via campo di pile 67100 L'aquila See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Cinzia D'ettore (Dr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITY COLLEGE LONDON United Kingdom EU contribution € 286 050,00 Address Gower street WC1E 6BT London See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Administrative Contact Kamilla Kolasinska (Ms.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITATSKLINIKUM ERLANGEN Germany EU contribution € 173 921,42 Address Maximiliansplatz 2 91054 Erlangen See on map Region Bayern Mittelfranken Erlangen, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Katrin Faber (Dr.) Links Contact the organisation Opens in new window Website Opens in new window QENDER SPITALORE UNIVERSITARE NENEA TIRANE Albania EU contribution € 129 686,42 Address Rr dibres 370 1001 Tirana See on map Activity type Higher or Secondary Education Establishments Administrative Contact Dollani Mirjel (Dr.) Links Contact the organisation Opens in new window ASSISTANCE PUBLIQUE HOPITAUX DE PARIS France EU contribution € 295 789,92 Address 55 boulevard diderot 75012 Paris See on map Region Ile-de-France Ile-de-France Val-de-Marne Activity type Research Organisations Administrative Contact Alix Pillot (Ms.) Links Contact the organisation Opens in new window Website Opens in new window CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION Participation ended Spain EU contribution € 0,00 Address Plaza pablo picasso 9 3 d 46015 Valencia See on map Activity type Other Administrative Contact Patricia Brouwer (Dr.) Links Contact the organisation Opens in new window Website Opens in new window CHILDHOOD CANCER INTERNATIONAL Netherlands EU contribution € 49 000,00 Address Kraijenhoffstraat 137 a 1018 RG Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Other Administrative Contact Patricia Brouwer (Dr.) Links Contact the organisation Opens in new window Website Opens in new window ISTITUTO GIANNINA GASLINI Italy EU contribution € 85 562,16 Address Via gerolamo gaslini 5 16147 Genova See on map Region Nord-Ovest Liguria Genova Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Maria Gabriella Marinari (Mrs.) Links Contact the organisation Opens in new window Website Opens in new window GENIKO NOSOKOMEIO PAIDON ΑTHINON I AGIA SOPHIA - PAIDON PENTELIS Greece EU contribution € 158 122,43 Address Thivon and papadiamantopoulou 1 115 27 Athina See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Eleana Garini (Dr.) Links Contact the organisation Opens in new window Website Opens in new window
