In a long-term open extension trial of CBD in patients with Lennox-Gastautsyndrome (LGS ) the plant cannabinoid was effective in reducing seizure frequency for up to 156 weeks. Patients received plant-derived highly purified CBD (Epidiolex in the United States; Epidyolex in the EURopean Union; 100 mg/ml oral solution), titrated to a target maintenance dose of 20 mg/kg/day over 2 weeks. Based on response and tolerability, CBD could then be reduced or increased up to 30 mg/kg/day.
Of 368 patients with LGS who completed several randomised controlled trials at several hospitals and universities in Poland, the Netherlands, the UK and the USA 366 (99.5%) enrolled in this long-term observational study. Mean treatment duration were 826 days with a mean daily dose of 24 mg/kg/day. Common adverse effects were convulsion (39%), diarrhoea (38%), fever (34%), and somnolence (29%). Fifty-five (15%) patients experienced liver transaminase elevations more than three times the upper limit of normal. Median percent reductions from baseline ranged 48%-71% for drop seizures and 48%-68% for total seizures through 156 weeks. Authors concluded that their study is “demonstrating long-term benefits of CBD treatment for patients with LGS.”
