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Content archived on 2024-06-18

Development of an innovative paediatric formulation of an antiepileptic agent for the treatment of absence epilepsy in children

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 (EuroSciVoc)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

FP7-HEALTH-2011-single-stage
See other projects for this call

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

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
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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Participants (3)

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