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GAbapentin in Paediatric Pain

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.

Coordinator

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Address

Via Nicolo Putignani 178
70122 Bari

Italy

Activity type

Research Organisations

EU Contribution

€ 1 224 676,25

Administrative Contact

Donato Bonifazi (Mr.)

Participants (15)

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DOMPE SPA

Italy

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 438 138,50

FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS

Italy

EU Contribution

€ 367 088,75

SOCIETA SERVIZI TELEMATICI SRL

Italy

EU Contribution

€ 359 000

AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI

Italy

EU Contribution

€ 136 690,50

PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRLIN SRL

Italy

EU Contribution

€ 647 200

SIHTASUTUS TARTU ULIKOOLI KLIINIKUM

Estonia

EU Contribution

€ 156 540,50

DOMPE FARMACEUTICI SPA

Italy

EU Contribution

€ 713 500

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 260 300

UNIVERSITATSKLINIKUM ERLANGEN

Germany

EU Contribution

€ 181 918

QENDRES SPITALORE UNIVERSITARE NENETEREZA TIRANE

Albania

EU Contribution

€ 164 455

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 450 320,50

CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION

Spain

EU Contribution

€ 49 000

ISTITUTO GIANNINA GASLINI

Italy

EU Contribution

€ 148 791,25

GENIKO NOSOKOMEIO PAIDON ΑTHINON I AGIA SOPHIA - PAIDON PENTELIS

Greece

EU Contribution

€ 179 255,75

Project information

Grant agreement ID: 602962

Status

Closed project

  • Start date

    1 July 2013

  • End date

    30 June 2017

Funded under:

FP7-HEALTH

  • Overall budget:

    € 7 189 924,25

  • EU contribution

    € 5 476 875

Coordinated by:

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Italy