CloSed Project Kick-Off Meeting
Erlangen, December 3rd 2013. A new research challenge is represented by the new European project CloSed – Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (602453-FP7-HEALTH-2013-INNOVATION-1), which officially kicked off in Erlangen, Germany, on December 2nd-3rd 2013. Funded under the 7th Framework Programme, the five-year project will be coordinated by the University Hospital of Erlangen, Germany.
The project Consortium comprises ten partners; one not-for-profit organisation, five clinical centres, one SME pharmaceutical company, two universities and one patient organisation, all focused on developing appropriate medicines for children. “Clonidine is an established drug commonly used to treat hypertension in adults. As well as lowering blood pressure it also has other effects such as sedation. However, there is a lack of data regarding the use of clonidine in this indication for severely ill paediatric patients. “In CloSed we will close this knowledge gap”, outlined Scientific Coordinator Antje Neubert, who opened the two-day event giving an overview of the project and highlighting the invaluable combination of expertise of the ten partners. The Project aims to develop an age-appropriate intravenous formulation of clonidine and to test its efficacy and safety for sedation of children treated in the Intensive Care Unit.
“CloSed will not simply generate safety and efficacy data for clonidine in paediatric patients, but following positive results in the clinical trial, it should lead to a Paediatric Use Marketing Authorisation (PUMA) thus making the authorised drug commercially available for use in paediatrics in the whole of Europe”, commented Jackie Winslade from Therakind Ltd. In preparation for this, a Paediatric Investigation Plan (PIP) has already been agreed with the EMA-PDCO.
Prior to the clinical trial, pharmacokinetic (PK) parameters will be calculated using a population-based approach. For the purpose of pharmacodynamics (PD) evaluation, the COMFORT-B score will be used. The CloSed trial will involve sites located in five EU Countries: Czech Republic, the Netherlands, Sweden, Germany and Italy and will recruit 300 patients.
From the European patients perspective, a CloSed Patient Advisory Board (PAB) will be established. The PAB will be managed by Vereniging Samenwerkende Ouder- and Patientenorganisaties (VSOP) national patient umbrella organisation in the Netherlands. From the ethical point of view, Tuuli Metsvaht of the University of Tartu outlined the critical aspects and concluded that “An uniformity of procedures must be ensured in order to achieve high-level ethical standards. In a multinational trial, such as the one planned in the CloSed project, compliance must be achieved with legislation in each participating country”. In this context, Viviana Giannuzzi from the Gianni Benzi Pharmacological Research Foundation mentioned two important aspects of the study, namely that it will be conducted in five different countries and that it will enrol children as patients. “As a consequence, specific submission packages must be prepared for each country, taking into account a number of guidelines and directives”, stressed Viviana Giannuzzi.
The meeting was an occasion for the project clinicians to discuss and share their experience in sedation in PICU, local practices, the use of different medications and dose regimens. The main focus of discussion was the CloSed clinical trial, which was considered in detail, covering such aspects as study protocol and trial design, control group, recruitment, dose regimens and formulation.
All partners were present at the meeting, which aimed to give all participants a detailed understanding of the tasks and goals of the project.