GAPP

Gabapentin in Paediatric Pain (GAPP)

Background
Chronic pain is estimated to affect 15-20% of children with underlying conditions and is often pproly recognized and treated. To date opoids, non-steroid anti-inflammatory drugs (NSAID’s), antidepressants and anticonvulsants are among the most commonly used medications to treat pain, but very few of these are formulated orauthorized for paediatric use.

The GAPP project aims to improve the therapuetic prospects of children suffering from chronic pain with a neuropathic component, by developing a new paediatric formulation of gabapentin, a drug proven to be efficacious and safe in adults with neuopathic pain and in children with epilepsy. Gabapentin was included in the EMA-PDCO Priority list of off-patent medicines for which clinical development is strongly supported to respond to unmet medical needs.

Objectives.
The projects main goal is to demonstrate the efficacy and safety of gabapentin in children aged 3 months to 18 years suffering from chronic pain with a neuropathic component, using a new age appropriate liquid oral formulation developed as part of the research programme.

Within the research programm the consortium will

  • conduct a pre-clinical toxicity study (preGABA) aimed to verfy the potentials effects of high doses of gabapentin on the development of the mammalian nervous system.
  • collect pharmacokinetic data on gabapentin and identify optimal paediatric dosages for patients aged 3 months to 18 years
  • conduct two randomized, controlled trials to evaluate efficacy and safety of gabapentin in patients between 3 months and 18 years of age with moderate and severe chronic pain with a neuropathic component. (GABA 1 and GABA 2)
  • conduct a bridging modelling study to extrapolate GABA 1 and GABA 2 results to children between 3 months and 3 years of age, adressing the paucity of data in this age group.

Coordinator: CVBF
Startdate: Juli 1st, 2013
Duration: 48 months
Consortium: 15 partners
Budget: 7,2 million euro
EU contribution: 5,5 million euro

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