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• W3214549475 abstract "Objective: The objective of this study was to evaluate quality of life (QoL) and caregiver qualitative changes in children with developmental and epileptic encephalopathies (DEEs) who were treated with a cannabidiol (CBD) transdermal gel. Background: The most severe group of epilepsies, DEEs, are characterized by frequent epileptiform activity that contributes to severe cognitive impairment and often, behavioral disturbances. Patients are typically drug-resistant and frequently have severe to profound disability with comorbidities including autism spectrum disorder, cerebral palsy, gait abnormalities, respiratory disorders and infections, gastrointestinal problems, and an increased mortality risk. Design/Methods: This was an open-label, multiple-dose study in children and adolescents with DEEs aged 3 to Results: Of the 48 participants enrolled, 54.2% (26/48) were male. Mean (SD) results on the ELDQOL (N=40) showed significant improvements at Week 26 compared with baseline in seizure severity (−0.19 [0.428], p=0.008); behavior (−0.21 [0.384], p=0.001); and mood (−0.15 [0.270], p=0.001). Caregiver qualitative assessments (N=43) were consistent with improvements noted in the ELDQOL scale and included improvements in alertness, awareness, or energy (58%); seizures (51%); cognition/concentration (47%); socially-avoidant behaviors (37%); and school attendance (28%). Twenty-nine (60.4%) participants had ≥1 related adverse event over 26 weeks; 93% were mild or moderate. Conclusions: Treatment with CBD transdermal gel may be associated with significantly improved cognitive and socio-behavioral symptoms and increased QoL in children and adolescents with DEEs and their families. Disclosure: Dr. Sadleir has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Zynerba Pharmaceuticals. Dr. Sadleir has received research support from Zynerba Pharmaceuticals.Dr. Hulihan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Zynerba Pharmaceuticals and Finn Partners. Dr. Messenheimer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Zynerba, SK Life Sciences, Aquestive. Dr. Ali has nothing to disclose. Dr. Gutterman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Zynerba Pharmaceuticals. Dr. Sebree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Zynerba Pharmaceuticals. Dr. Scheffer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with scientific advisory boards for BioMarin, Nutricia, GSK, Xenon Pharmaceuticals, UCB, received speaker honoraria, support for travel from BioMarin, UCB, GSK, Eisai. Dr. Scheffer has received royalty, license fees, or contractual rights payments from Royalty payment received for PCT/AU2012/001321. Dr. Scheffer has received research support from Trial investigator for GW Pharma, Zogenix, UCB, Ultragenyx, Ovid Therapeutics, Zynerba." @default.
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• W3214549475 date "2020-04-14" @default.
• W3214549475 modified "2023-09-27" @default.
• W3214549475 title "Quality of Life and Qualitative Caregiver Assessments in Children and Adolescents with Developmental and Epileptic Encephalopathies Treated with Cannabidiol Transdermal Gel: An Open-label Clinical Trial (1664)" @default.
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