CBD gel reduces seizures in children with DEE: BELIEVE trial
Australia: Cannabidiol (CBD) transdermal gel (ZYN002, Zygel) helped to reduce seizure frequency in children and adolescents with developmental and epileptic encephalopathies (DEE), show results from phase II BELIEVE trial.
The findings of the study were presented at the American Epilepsy Society 2020 virtual annual meeting.
DEE are the most severe group of epilepsies. Children have drug-resistant seizures, developmental slowing often with regression, and psychiatric and motor disabilities. BELIEVE trial by Ingrid Scheffer, the University of Melbourne, Australia, and colleagues evaluated the safety, tolerability, and efficacy of cannabidiol transdermal gel in children and adolescents with DEEs.
BELIEVE was an exploratory open‐label, multiple‐dose study of ZYN002 CBD transdermal gel in children and adolescents (aged 3 to < 18 years) with DEEs. During a 26‐week treatment period, weight-based doses of ZYN002 125, 250, 375, or 500 mg were applied every 12 hours. After a 4-week baseline period, the children were treated with ZYN002 at a twice daily dose of 125mg (< 25kg) or 250mg ( >25kg). Doses could be titrated up to a dose of 375mg (< 25kg) or 500mg ( >25kg) twice a day.
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