Professor Terry O’Brien has led a transdermal CBD gel trial in adults with focal epilepsy. After 6 months of treatment, more than half of the patients experienced a 50% reduction in seizures.
Professor Terry O’Brien has led a transdermal CBD gel trial in adults with focal epilepsy. After 6 months of treatment, more than half of the patients experienced a 50% reduction in seizures. Study JAMA
Cannabis-based medical treatments are emerging as promising complementary approaches to improving seizure control in patients with difficult-to-treat epilepsy. In 2018, the U.S. Food and Drug Administration (FDA) approved the use of a prescription drug cannabidiol for the treatment of two rare epileptic diseases that cause treatment-resistant seizures, Lennox-Gastaut syndrome and Dravet’s syndrome, which predominantly affect children.
Last year, the Australian Therapeutic Products Administration (TGA) and the Pharmaceutical Benefits Advisory Committee (PBAC) approved the prescription and grant in the Pharmaceutical Benefits Program (PBS) for this treatment for patients with Dravet’s syndrome. However, there is currently limited high-level evidence on the efficacy and safety of cannabidiol treatments, and their availability, for adults with common forms of epilepsy.
A phase 2A trial for the first time in the world, led by Professor Terry O’Brien, director of the Department of Neuroscience at Monash University and director of the Alfred Brain program, and published in the Journal of the American Medical Association (JAMA Open), analyzed the safety of Transdermal Cannabidiol Gel (CBD) in adults with focal epilepsy, which is the most common form of epilepsy in adults (affects 60% of patients) and is resistant to treatment in one-third of patients.
The study, conducted in 14 epilepsy testing centers in Australia and New Zealand, found that the use of CBD oil in skin patches was safe, well tolerated and accepted by patients. It is important to note that while the initial double-blind phase of the 12-week trial of 188 patients did not find a significant difference in the frequency of seizures between patients randomized to one of the two arms of oil treatment. CBD compared with those randomized to receive placebo (inactive). ice, there was a reduction in seizures in at least 50% in more than half of the patients at month 6 of the open follow-up extension trial.
According to Professor O’Brien, this is the first such trial in the world on the efficacy and safety of a medicinal cannabidiol for the treatment of the frequency of seizures in adults with focal epilepsy.
“This is the first randomized, double-blind, placebo-controlled trial of a cannabidiol in this common group of adult patients, whose seizures cannot currently be controlled with currently available treatments,” he said.
“The original 12-week trial showed no difference in the effect of ice between the experimental group and the placebo group, although the trial showed that the ice was safe. It is important to note that the extent of label of the six-month trial showed a seizure reduction of at least 50% in more than half of the experimental group, making it a promising candidate for larger, longer trials .This trial represents an internationally significant benchmark trial, to build an evidence base to support the availability and use of medical cannabis-based treatments for adults with common forms of epilepsy. “
See the paper
O’Brien TJ, Berkovic SF, French JA, Messenheimer JA, Sebree TB, Bonn-Miller MO, Gutterman DL; STAR 1 / STAR Study Group 2. Adjunct transdermal cannabidiol for adults with focal epilepsy: a randomized clinical trial. JAMA Netw Open. July 1, 2022; 5 (7): e2220189. doi: 10.1001 / jamanetworkopen.2022.20189. PMID: 35802375.
