TUESDAY, Dec. 10, 2019 (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 Dec. 6 to 10 in Baltimore.
Elizabeth Thiele, M.D., Ph.D., 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; 100 mg/mL) at a dose of 25 mg/kg/d (CBD25) or 50 mg/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 percent for CBD25, 48 percent for CBD50, and 27 percent for placebo. Based on patient/caregiver global impression of change, improvement in overall condition was reported by 69 percent of patients/caregivers for CBD25 (odds ratio, 2.25) and 62 percent for CBD50 (odds ratio, 1.77) versus 40 percent for placebo. While most adverse events were mild or moderate, 93 percent of patients in the CBD25 group, 100 percent in the CBD50 group, and 95 percent in the placebo group had an adverse event, including diarrhea, decreased appetite, and somnolence. Treatment was discontinued by eight 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.
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