The primary objective of the GAPP Project is to assess gabapentin side effects and efficacy in children from 3 months of age to less than 18 years of age testing a new paediatric oral liquid formulation.
The specific objectives are:
- to develop a new oral liquid formulation of gabapentin suitable for use in children;
- to perform 2 controlled efficacy and safety clinical trials in children from 3 months to less than 18 years of age, with moderate and severe pain (called GABA1 and GABA2, respectively);
- to perform a bridging study to specifically address the paucity of data available from children ranging from 3 months to 3 years old (GABA-3). This study will integrate data collected in the clinical studies proposed above;
- to perform a toxicity study (preGABA) for the investigation of the potential toxic effects of gabapentin on the central nervous system development.