100
Participants
Start Date
October 14, 2022
Primary Completion Date
June 14, 2026
Study Completion Date
June 14, 2026
Video-electroencephalography
All patients will be monitored 24 hours. Whenever possible, duration of the long-term monitoring will be extended to 48 hours, including a second full night polysomnography. These recordings will also allow us to assess sleep architecture and to capture seizures in some patients video , EEEG, EKG, respiration and other polysomnography data will be centralized at Hospices Civils de Lyon. A copy of the EEG-EKG data required to address the objectives related to cardiac features will then be electronically transferred to Partner 2 (Bonn) Evaluation will be performed blind to other data by the Partner 1 (Lyon) for the respiratory data and by the Partner 2 (Bonn) for the EKG data All primary outcomes and secondary outcomes will be assessed with respect to duration of epilepsy and frequency of convulsive seizures during the baseline period.
Blood Samples
Blood samples will be collected at V2 in all patients. A total of seven blood samples of 4 ml each will be collected, including five EDTA and two dry. Samples EDTA plasma and serum will then be prepared after centrifugation. In children \< 10 kg, only 5 samples of 4 ml each (22 ml in total), including four EDTA and one dry.
NOT_YET_RECRUITING
Department of Paediatrics and Paediatric Neurology, Antwerp University Hospital, Edegem
NOT_YET_RECRUITING
Klinik und Poliklinik für Epileptologie, Universitätsklinikum, Bonn
RECRUITING
HFME Hospices Civils de Lyon, Bron
RECRUITING
Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon, Bron
Hospices Civils de Lyon
OTHER