A “world-first” trial in Australia and New Zealand of transdermal CBD gel in adults with focal epilepsy has found that most patients experience a reduction in seizures.
Focal epilepsy is a condition in which the main symptom is recurrent seizures that affect half of the brain. It is the most common form of epilepsy in adults, and in a third of these patients the disease is resistant to treatment.
A phase 2A trial led by Professor Terry O’Brien of Monash University examined the safety of transdermal cannabidiol gel (CBD) in adults with focal epilepsy. The trial was conducted at 14 epilepsy trial centers in Australia and New Zealand with 188 patients aged 18 to 70 years.
Some of these patients received one of two treatments with CBD oil (195 mg and 390 mg cannabidiol), the others a placebo gel. In the first 12 weeks of the trial, the double-blind treatment period, there was no significant difference in seizures between the groups. However, seizures were reduced by at least 50% in more than half of the patients at month 6 in an open-label extension study.
It is important to note that the test results indicated that ice was well tolerated.
“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,” said Professor O ’ Brien.
More information on the trial and results has been published in the Journal of the American Medical Association (JAMA Open).
“Although active treatment groups did not separate from placebo during blinded treatment, rates of long-term seizures in cannabidiol-treated participants were reduced compared to what might be expected in an adult population. with focal seizures, ”the study concludes. “As a result, additional randomized, well-controlled clinical trials that use higher doses of transdermal cannabidiol in this patient population appear to be warranted.”
Professor O’Brien is director of the Department of Neuroscience at Monash University and described the trial as the first randomized, double-blind, placebo-controlled trial of a cannabidiol in this group of patients.
