Website
Role of CVBF
Coordinator
Description
The GAPP (GAbapentin in Paediatric Pain) project is intended to improve the therapeutic perspectives of children who suffer from chronic pain, providing them with a drug, gabapentin, which seems to be effective and safe, as already demonstrated in adults, and which was included in the European priority list of off-patent paediatric medicines worthy of research grants.
A comprehensive development strategy has been put in place including a new paediatric formulation, a non-clinical study and two clinical trials. Such strategy was agreed with the Paediatric Committee (PDCO) at the EMA in January 2013 and in July the GAPP Project officially started. During the course of the project a new formulation was developed, a juvenile preclinical study was conducted and the two clinical studies were formally activated in all recruiting centers. In July 2017, the project officially terminated, but the trials were not yet concluded. Due to the strong interest and commitment of the Parties, and in particular of the studies’ Sponsor (PHARM srl), it was decided to take over the continuation of the GAPP studies through a fund raising.
At the end of the project and on the basis of the study results, an application for a Paediatric Use Marketing Authorisation (PUMA) for the treatment of chronic pain in children both as monotherapy and as adjuvant therapy will be submitted by the commercial partner of the approved Project.
Funds
Seventh Framework Programme, European Commission
Budget
7.2 million euro
EU Contribution
5.4 million euro
Duration
2013- 2017
Partners
(1) Consorzio per le Valutazioni Biologiche e Farmacologiche (CVBF), Italy; (2) Erasmus Universitair Medisch Centrum Rotterdam (EMC), The Netherlands; (3) Fondazione Penta (PENTA), Italy; (4) Società Servizi Telematici S.r.l. (PEDIANET), Italy; (5) Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (PB), Italy; (6) Pharmaceutical Research Management Srl (PHARM), Italy; (7) Sihtasutus Tartu Uelikooli Kliinikum (TUH), Estonia; (8) Dompé S.p.A. (DOMPE’), Italy; (9) University College London (UCL), United Kingdom; (10) Universitätsklinikum Erlangen (UKER), Germany; (11) Qender Spitalore Universitare Nenea Tirane (QSUNT), Albania; (12) Assistance Publique – Hopitaux Paris, France; (13) Confederacion Internacional de Organizaciones de Padres di Ninos con Cancer Asociacion (ICCCPO), Spain; (14) Istituto Giannina Gaslini (IGG), Italy; (15) Geniko Nosokomeio Paidon Athinon I Agia Sophia – Paidon Pentelis (AGIA SOPHIA), Greece.