Encephalopathy with Electrical Status Epilepticus in Sleep (ESES) syndrome is a rare epilepsy syndrome of childhood that is characterized by disturbed electrical brain activity (epilepsy) in sleep and problems with cognition (attention, memory, language, etc.) or behavior. ESES resolves spontaneously in puberty, but cognitive problems often remain. Adequate treatment is mandatory to prevent or reverse these cognitive deficits. However, it is unknown which treatment is the best. Treatment with "standard" anti-epileptic drugs is not very effective. Some studies suggest that clobazam (benzodiazepine) and steroid treatment may be the best option. The only way to prove which treatment is best is to randomly allocate which treatment a child gets and then compare the effects of both treatments. The aim of this study is to establish which of the currently used treatment is best for children with ESES syndrome, by treating children with ESES syndrome with steroids (inflammation inhibitors) or clobazam and evaluating change in cognitive functioning after 6 and 18 months.
130 children aged 2 up to 12 years with a recent diagnosis of ESES syndrome will participate in the study.
The study is run from the Brain Center Rudolf Magnus, department of Pediatric Neurology, University Medical Center Utrecht in the Netherlands. The ECRIN network (European Clinical Research Infrastructure network) supports the transnational access of this study to several European Union countries and include Italy (Pavia), France (Paris, Lyon, Strasbourg), United Kingdom (London, Edinburgh, Glasgow), Belgium (Brussels, Leuven), Germany (Kehl, Freiburg, Kiel, Vogtareuth), Denmark (Dianalund), Finland (Helsinki), Romania (Bucharest), Bulgaria (Sofia) and Spain (Madrid).
The CIEC trough the ECRIN network will manage the 3 sites located in Belgium: UZ Brussel, UZ Leuven and ULB Erasme.
Additional information on this trial is available on our website under following link: www.luxclin.lu/Studies/Details/?c=STP6722WHN
Reference: http://www.isrctn.com/ISRCTN42686094
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