HealthDay News – Among patients with tuberous sclerosis complex (TSC), the reduction in the frequency of TSC-associated seizures was greater in those receiving a purified version of cannabidiol (CBD) than in those receiving placebo, according to a study presented at the annual meeting of the American Epilepsy Society, held from December 6 to 10 in Baltimore.
Elizabeth Thiele, MD, PhD, from Massachusetts General Hospital, and colleagues randomly assigned 224 patients aged 1 to 65 years (2:2:1:1) with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC) to receive either a plant-derived pharmaceutical formulation of highly purified CBD in oral solution (Epidiolex; 100mg/mL) at a dose of 25mg/kg/d (CBD25) or 50mg/kg/d (CBD50) or matched placebo for 16 weeks (four-week titration and 12-week maintenance phase).
The researchers found that the median baseline monthly TSC-associated seizure frequency was 56 for CBD25, 61 for CBD50, and 54 for placebo. There was a significantly greater percent reduction in TSC-associated seizure frequency associated with CBD versus placebo: 49% for CBD25, 48% for CBD50, and 27% for placebo. Based on patient/caregiver global impression of change, improvement in overall condition was reported by 69% of patients/caregivers for CBD25 (odds ratio, 2.25) and 62% for CBD50 (odds ratio, 1.77) vs 40% for placebo. While most adverse events were mild or moderate, 93% of patients in the CBD25 group, 100% in the CBD50 group, and 95% in the placebo group had an adverse event, including diarrhea, decreased appetite, and somnolence. Treatment was discontinued by 8 patients taking CBD25, 10 taking CBD50, and two taking placebo due to an adverse event.
“Our findings suggest this formulation of purified CBD offers patients with TSC a new treatment option for their very difficult-to-manage seizures,” Thiele said in a statement.
The study was funded by GW Research Ltd., the manufacturer of Epidiolex.