Cannabidiol (CBD), a compound derived from the cannabis plant that does not produce a “high” and has been an increasing focus of medical research, was shown in a new large-scale, randomized, controlled trial to significantly reduce the number of dangerous seizures in patients with a severe form of epilepsy called Lennox–Gastaut syndrome.
In the new study comparing 2 doses of CBD to a placebo, the researchers reported a -41.9% reduction in “drop seizures” (a type of seizure that results in severe loss of muscle control and balance) in patients taking a 20 mg/kg/d CBD,
-a 37.2 percent reduction in those on a 10 mg/kg/d CBD and
-17.2 percent reduction in a group given a placebo.
“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy and, importantly, is the first study of its kind to offer more information on proper dosing,”
says Dr. Devinsky.
“These are real medications with real side effects, and as providers we need to know all we can about a potential treatment in order to provide safe and effective care to our patients.”
Safety of Two CBD Doses Studied
Lennox–Gastaut syndrome is a rare and severe form of epilepsy characterized by frequent drop seizures and severe cognitive impairment. Six medications are approved to treat seizures in patients with the syndrome, but disabling seizures occur in most patients despite these treatments.
Researchers enrolled 225 patients, age 2 to 55, with Lennox–Gastaut syndrome across 30 international sites in a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of 2 doses of CBD:
-76 patients received 20 mg/kg/d CBD,
-73 received 10 mg/kg/d CBD,
-76 were given a placebo.
All medications were divided into 2 doses per day for 14 weeks.
The number of seizures were monitored beginning 4 weeks prior to the study for baseline assessment, then tracked throughout the 14-week study period and afterwards for a 4-week safety check.
Side effects occurred in:
-94% of patients in the 20 mg CBD group,
-84% in the 10 mg CBD group,
-72% of those taking placebo.
Side effects were generally reported as mild or moderate in severity and included sleepiness, vomiting, diarrhea, fever, decreased appetite, and upper respiratory infection.
-43 patients taking CBD experienced dose-related, elevated liver enzymes that were reversible.
-7 participants from the CBD group withdrew from the trial due to side effects compared to one participant in the placebo group.
“While the news gives hope for a new treatment option to the epilepsy community, more research remains imperative to better determine the effects of CBD and other similar cannabis-derived compounds on other forms of the disease and in more dosing regimens,” says Dr. Devinsky.
Those findings represented the first large-scale, randomized clinical trial for the compound. Open label CBD studies led by Dr. Devinsky also have shown positive results for treatment-resistant epilepsies.
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