24 December 2013
On 19th December 2013 the database lock date of the Levamisolstudy was reached. All clinical data has now been provided. All adverse events are classified and all co-medication has also been entered into the database.
Parallel to the analysis of the clinical data, after deblinding, the statistical analysis of the pharmacokinetic data can be started. From 2007 to 2012, 103 patients of 7 countries have been included.
ACE is responsible for the design of the study protocol, producing and distributing the clinical trial medication, pharmacokinetics and monitoring.
Professor Jean Claude Davin and pediatrician Mariken Gruppen of the AMC (Academic Medical Center, Amsterdam) were acting as principal investigator (JCD) and study coordinator.
ACE will use the results as a pivotal study for the European authorisation (EMA) of the Orphan Drug ELMISOL®.