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GAbapentin in Paediatric Pain

Obiettivo

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.

Campo scientifico

Programma(i)

Argomento(i)

Invito a presentare proposte

FP7-HEALTH-2013-INNOVATION-1
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Meccanismo di finanziamento

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

Coordinatore

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Contributo UE
€ 1 463 082,22
Indirizzo
VIA NICOLO PUTIGNANI 178
70122 Bari
Italia

Mostra sulla mappa
Regione
Sud Puglia Bari
Tipo di attività
Research Organisations
Contatto amministrativo
Donato Bonifazi (Mr.)
Collegamenti
Costo totale
Nessun dato

Partecipanti (16)

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Ultimo aggiornamento: 25 Marzo 2022

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Permalink: https://cordis.europa.eu/project/id/602962/it

European Union, 2024