Abstracts

Rationale: Studies indicate that CBD may be safe and effective in treating epilepsy. The potential benefits or adverse effects of CBD involving cognition, adaptive function, and general quality of life need to be determined. Methods: Participants (N = 42) between the age of 3-19 years with pharmacoresistant epilepsy were enrolled in an open label study of a pharmaceutical formulation of CBD (Epidiolex®; GW Research Ltd) as an add-on treatment of epilepsy. In addition to assessing several baseline medical variables, assessment of cognitive status and quality of life was performed. After one year of participation in the trial, the participants were re-assessed to determine if there had been any significant changes in cognition and general quality of life. Cognitive status was assessed with the NIH Toolbox. Participants’ quality of life (QOL) was estimated by administration of the Quality of Life in Childhood Epilepsy (QOLCE). Many participants were not able to complete the computerized cognitive assessment battery due to the magnitude of their cognitive impairment, and in these cases, the participant’s caregiver was asked to complete the Adaptive Behavior Assessment System – Second Edition (ABAS-II) to estimate general functional status. Results: Twenty-four participants remained in the study at one-year follow-up. Six of these participants were able to complete at least portions of the NIH Toolbox computerized test battery. Caregivers of ten of the participants who could not complete the NIH Toolbox computerized test battery completed the ABAS as a measure of functional adaptive status. There were no significant changes in overall cognitive or functional adaptive status in the sample after one year of participation in the trial. QOL was reported by caregivers as significantly improved (p < 0.05) with a mean increase of 12.59 points (SD = 19.99) in overall QOLCE score. Conclusions: Data collection is ongoing in this study, but based upon preliminary analyses, CBD as an add-on drug for the treatment of pharmacoresistant epilepsy in a pediatric population does not appear to cause adverse effects involving cognition or adaptive function in patients who completed one year of treatment. Caregivers reported an overall improvement in QOL. Funding: Study funding provided by the State of Alabama through Carly’s Law (SB174)