Objective The KIEKIDS project is dedicated to the development of an innovative paediatric formulation of an antiepileptic agent for a safe alternative treatment of absence epilepsy in children.Development of such an age-appropriate formulation is regarded by The European Medicines Agency (EMA) to be amongst one of highest priorities for the treatment of absence seizures, using a drug with identified and documented efficacy in the target population.The KIEKIDS project has gathered a very strong consortium of well trained and qualified partners from industry, academy, and hospital with extensive experience in drug development in clinical, pharmacological, data analysis and regulatory areas. The proposed strategy for KIEKIDS implies to develop a dedicated paediatric formulation with sustained delivery and to conduct a clinical programme, which will be endorsed by approval of the Paediatric Investigation Plan (PIP).The consortium is coordinated by the Unit 663 of INSERM (INSERM U663), a French public organisation of research devoted to the paediatric epilepsies and brain plasticity. This consortium rallies all the competencies required to manage a paediatric drug development from the designing of an adapted formulation up to market. With its solid track record of clinical success in pharmaceutical and biotech companies, and its huge expertise in absence epilepsy, this consortium will be able to avoid the pitfalls of pharmaceutical drug development and is in a strong position to guarantee the success of the programme.The ultimate goal of KIEKIDS is to submit in 2015 this novel age-adapted paediatric formulation as a Paediatric-Use Marketing Authorisation, a PUMA, the tool identified by the EMA to bridge the gap for off-patent drugs. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverynatural sciencescomputer and information sciencesdata sciencemedical and health sciencesbasic medicineneurologyepilepsymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesclinical medicinepaediatrics Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2011.4.2-1 - Investigator-driven clinical trials on off-patent medicines for children Call for proposal FP7-HEALTH-2011-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE EU contribution € 451 705,00 Address RUE DE TOLBIAC 101 75654 Paris France See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Administrative Contact Nicolas Jeanjean (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (3) Sort alphabetically Sort by EU Contribution Expand all Collapse all ADVICENNE SA France EU contribution € 1 127 100,00 Address RUE GEORGES BESSE 155 30000 NIMES CEDEX 01 See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Caroline Roussel-Maupetit (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS Switzerland EU contribution € 279 946,00 Address RUE DU BUGNON 21 1011 Lausanne See on map Region Schweiz/Suisse/Svizzera Région lémanique Vaud Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Thierry Buclin (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CLINBAY SPRL Belgium EU contribution € 298 320,00 Address RUE BON AIR 30 1470 GENAPPE See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact François Vandenhende (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data