Background There is a paucity of high-quality evidence of the efficacy and safety of cannabis-based medicinal products in treatment of treatment-resistant epilepsy (TRE) in children. Methods A case series of children(<18 years old) with TRE from the UK Medical Cannabis Registry was analysed. Primary outcomes were ≥50% reduction in seizure frequency, changes in the Impact of Paediatric Epilepsy Score(IPES) and incidence of adverse events. Results Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following-CBD isolate oils(n=19), CBD broad-spectrum oils(n=17), and CBD/Δ9-THC combination therapy(n=17). Twenty-three(65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1%(n=16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6%(n=6) and 17.6%(n=3) of patients treated with CBD isolates and broad-spectrum CBD products respectively(p<0.001). Twenty-six(74.3%) adverse events were reported by 16 patients(45.7%). The majority of these were mild(n=12; 34.2%) and moderate(n=10; 28.6%). Conclusions The results of this study demonstrate a positive signal of improved seizure frequency in children treated with CBMPs for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series.
The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).