It was held in Pavia, on November 18th-20th 2013, the kick-off meeting of the first European project Framework Program for Research and Technological on pediatric chronic pain (GAPP-Gabapentin in Paediatric Pain, 602962-2-FP7-HEALTH-2013-INNOVATION-1) organised by the Consortium for Biological and Pharmacological Evaluation (CVBF), the project coordinator and was attended by 15 partners, European and not.
The project is financed under the 7th Development and will last 48 months.
Its aims is to study and make available on the market a drug for which the great therapeutic interest has been already demonstrated, the ‘Gapapentin’, in order to improve the quality of life in children with chronic pain, a widespread but poorly recognised problem, that is in most cases treated with drugs not approved or used off-label.
Through the development of two appropriately controlled clinical trials (GABA-1 e GABA-2), sponsored by Dompè SpA, one of the main biopharmaceutical industries in Italy and the industrial project partner, the project will investigate appropriate dosages, efficacy and safety of this drug in the treatment of paediatric pain. If the results of the studies will lead to positive results, it will be able to respond to an unmet therapeutic need.
During this meeting, many important topics were discussed, such the organisation of the planned studies, the support to the development of the drug in children, including the two clinical trials, and the formulation and pre-clinical study.
The kick-off meeting was also an opportunity to discuss and compare the practice for the diagnosis and treatment of paediatric neuropathic pain and the current regulations in the 15 countries involved in the project, and this comparison showed a difference between the centres, thereby highlighting the need to create a methodological and statistical group to the execution of clinical trials, in order to ensure the definitions and therapeutic schemes standardisation.
