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Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

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).

Latest News

21Dec

Site initiation EMC Rotterdam

The first CloSed trial site “Erasmus MC – Sophia Children’s Hospital” (EMC) in Rotterdam, the Netherlands was initiated on 2nd-3rd... Read More →
21Dec

Interview to Ms. Louise Rawcliffe from Therakind

The clinical study and the Marketing Authorisation Application (MAA) require specific regulatory prerequisites. For the CloSed project, these are managed... 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.

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