The European Commission has approved the project “Clonidine for sedation of paediatric patients in the paediatric intensive care unit” (CloSed) in the framework of FP7.

CloSed is coordinated by the University Hospital of Erlangen (Germany) and involves other partners from the United Kingdom, the Netherlands, Italy, Sweden, Estonia, Czech Republic and Belgium.

This project, meeting with an important paediatric therapeutic need, aims to develop an age appropriate, GMP manufactured clonidine formulation and to perform an efficacy and safety randomised phase III double-blind, active-controlled clinical trial involving children from birth to 18 years.

Clonidine is a drug used for sedation in Paediatric Intensive Care Units and recommended by guidelines in various countries, although there is a lack of evidence regarding its safety and efficacy in this setting.  This therapeutic need is also demonstrated by the inclusion of clonidine in the EMA “Revised Priority List for Studies into Off-patent Medicinal Products”.

The project is designed to fulfil the requirements for a most ethical research in the paediatric population in order to reduce risk for patients, avoid unnecessary studies and make use of already available data, as outlined in the Paediatric Regulation. The ultimate aim is to make available on the market clonidine for sedation in children and to apply for a Paediatric Use Marketing Authorisation (PUMA).

This will foster the conduct of clinical trials in children, increase the availability of paediatric medicines and establish international paediatric research collaborations.

Fondazione Gianni Benzi is one of the partners and will have a central role in regulatory, ethical, training and dissemination activities and will also contribute to the project management.