Clinical Outcome Data of Children Treated with Cannabis Based Medicinal Products for Treatment Resistant Epilepsy - Analysis from the UK Medical Cannabis Registry.

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.