GAPP - GAbapentin in Paediatric Pain

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Category
Project best practice
Date
15/05/2015 16:00 - 17:00
Place
1
Proposer organization
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)
Speakers (name and surname)
Donato Bonifazi/ Mariangela Lupo
Attachment

GAPP (GAbapentin in Paediatric Pain) is a European research Project (FP7) coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) with the aim to improve the quality of life of children affected by chronic pain, treated in most cases with drugs that are not authorised for paediatric use. In order to fulfil this gap,

GAPP aims to study and make available on the market a drug (Gapapentin), by developing controlled clinical trials to investigate the paediatric dosages and the efficacy and safety profile of Gabapentin in the treatment of paediatric chronic pain.
This goal is made possible thanks to a multidisciplinary approach, based on the collaboration between pharmacists, clinical neurologists and paediatricians from 9 European and non-European Countries, which resulted in the creation of a large international scientific Consortium with experienced professionals in the field of pain. Within GAPP, age-appropriate formulation will be developed and two randomised, comparator-controlled clinical trials (GABA-1 e GABA-2), 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 potential of the drug.
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.

For more information visit the GAPP project website.

 
 

All Dates

  • 15/05/2015 16:00 - 17:00
 

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