Cannabidiol in refractory childhood epilepsy, a personalized high-quality approach

Refractory Epilepsy

Change from baseline in daily seizure frequency during placebo periods compared to the change from baseline in daily seizure frequency during active treatment periods.

Change in score from baseline during placebo versus CBD treatment of: Quality of Life in Childhood Epilepsy (QoLCE-55); Global Assessment of Severity of Epilepsy (GASE); Clinical Global Impression of Change (CGI-C); Aberrant Behavior Checklist (ABC); Vineland Adaptive Behavior Score III (VABS-III); Sleep Disturbances Scale for Children (SDSC); Goal attainment scaling (GAS)., Number of (serious) adverse events, Clinical characteristics including: age; gender; epilepsy characteristics; etiology; comorbidity; co-medication., Measurements of neuronal excitability, measured on EEG and TMS-EMG: assessment of epileptic discharges on EEG; assessment of background activity on EEG; measurement of resting motor threshold on TMS-EMG; measurement of cortical silent period (CSP) on TMS-EMG., Pharmacogenetic assessment of CYP-enzymes such as CYP2C19, CYP2C9, and CYP3A4., Change in productivity loss measured by iMTA Productivity Cost Questionnaire; change in healthcare resources used measured by iMTA Treatment Inventory of Costs in Patients with psychiatric disorders for Children; change in health related quality of life measured by EuroQol Five-Dimensional Questionnaire, Youth version

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