CloSed is a 5-year project funded under the Seventh Framework Programme (FP7) with an international Consortium comprising 10 European partners and coordinated by Assoc. Prof. Antje Neubert, University Hospital of Erlangen.
The project aims to conduct a multicentre clinical trial of clonidine in children until the age of 18. Indeed, despite its widespread use in Pediatric Intensive Care Units (PICU), this drug still lacks authorisation for paediatric use. A parenteral age-appropriate formulation of clonidine for sedation in PICU will be developed and tested in order to obtain a Pediatric Use Marketing Authorisation (PUMA).
The next General Assembly Meeting of the CloSed Consortium will be held on March 20th to 21st in Erlangen, Germany.... Read More →
One of the key elements of the CloSed project is the study CLON01 (EudraCT Number: 2014-003582-24 ClinicalTrials.gov Identifier: NCT02509273). After having received full... Read More →
European Research in Paediatrics
EU Paediatric Regulation includes provisions for funding of research into off-patent medicines leading to PUMAs. In this context, the EU launched several calls under FP7 to develop age-appropriate formulations and/or delivery systems of off-patent drugs used in paediatrics, and the CloSed project has been selected for funding.