The trial is still recruiting at clinical sites in British Columbia, Manitoba, Quebec and Saskatchewan. More information is available here.
All seven children had fewer seizures while taking CHE at a CBD equivalent dose of 5–6 mg/kg per day, data showed. Six experienced a 25% drop in seizure frequency and four a decrease of more than 50%.
A team led by researchers at University of Saskatchewan, Canada, are conducting an open-label Phase 1 clinical study (NCT03024827) called CARE-E. Scientists are exploring the safety and impact of increasing doses of CBD-enriched cannabis herbal extract (CHE) used as add-on therapy in up 28 children (ages 1 to 10) with epileptic encephalopathy resistant to standard anticonvulsant therapy. The mixture, called CanniMed 1:20, contains 1 mg/ml of THC and 20 mg/ml of CBD.
Better quality of life was also reported, with greatest improvements being on the cognitive, social and emotional functioning subscales of the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55).
“The preliminary data suggest an initial CBD target dose of 5–6 mg/kg/day when a 1:20 THC:CBD CHE is used,” the study concluded. “The reduction in seizure frequency seen suggests improved seizure control when a whole plant CHE is used. Plasma THC levels suggest a low risk of THC intoxication when a 1:20 THC:CBD CHE is used in doses up to 12 mg/kg CBD/kg/day.”
“Tolerance” to the drug developed in about one-third of those patients after an average of seven months, the researchers said. So doctors needed to increase the dose by 30% to get the same seizure-reducing benefit.
“The current study tested CBD at doses of 10mg/kg and 20mg/kg, while the 2017 study examined only a dose of 20mg/kg,” said Lado, who is Northwell Health’s regional director of epilepsy for Queens and Long Island, N.Y.
The research found that the drug reduced seizures by nearly half in children with Dravet syndrome, a rare and severe form of the neurological disorder.
CBD products are derived from marijuana, but do not include THC, the active agent in pot that causes a “high.”
Seizures were reduced by half or more in 49% of the high-dose group, 44% of the low-dose group, and 26% of the placebo group.
The only big difference between the new trial and that 2017 New England Journal of Medicine study is in the dosages given, explained neurologist Dr. Fred Lado.
Both doses were nearly equivalent in effectiveness, he said, and “the new results hint that the lower dose CBD is better-tolerated.”
There are many treatments for seizures in children, but not all children respond to one or more of them. Cannabis oil is a new and sometimes controversial treatment that is currently gaining ground as a natural and non-invasive way to keep seizures under control.
Far from being the stereotypical drug that makes a person want to eat snacks and watch television all day, cannabis contains chemicals that are able to work with the body to ease seizures. The two major components of cannabis are tetrahydrocannabinol (THC) and cannabidiol (CBD).
How Does Cannabis Oil Benefit?
THC is the component of cannabis that produces the characteristic euphoric state often referred to as a “high.” Cannabidiol does not produce psychoactive effects, but has been shown to promote positive effects in different parts of the body. Cannabidiol is the component in cannabis that is hypothesized to ease seizures in children.
Cannabis is the proper name for marijuana, a cousin of the hemp plant and one that has long been classified as an illegal substance. However, with many states now opting to legalize cannabis for medical use, research is being conducted on how it can be used to treat seizures in children with epilepsy.
Cannabis oil that contains very low amounts of THC or none at all is preferred for use as medicine. This oil can be made from both marijuana and hemp plants. Hemp strains often contain CBD without THC.