Philanthropy – A cannabis drug cannabinoid reduces the seizures by nearly half for children with a rare and severe type of epilepsy called Dravet's syndrome, according to a Phase 3 study released today at the American Academy. of the 71st Annual Meeting of Neurology in Philadelphia, May 4-10, 2019. Dravet syndrome, which begins in childhood, can lead to intellectual disability and frequent and prolonged seizures. Cannabidiol is derived from marijuana that does not include the psychoactive part of the plant that creates a "high".
"It is exciting to be able to offer another alternative for children with this debilitating form of epilepsy and their families," said study author Ian Miller, MD, of Nicklaus Children's Hospital, formerly Miami Children's Hospital, in Florida. "The children in this study had already tried an average of four unsuccessful epilepsy drugs and at the time were taking an average of three additional drugs, so having that measure of success with cannabidiol is a big win."
The study involved 199 children with a mean age of 9 years who were divided into three groups. One group received 20 milligrams per kilogram (mg / kg) per day of cannabidiol, the second group received 10 mg / kg per day and the third group received a placebo.
Seizures were recorded for four weeks before treatments were initiated to establish a baseline. Participants were then treated for 14 weeks. At the end of the study, seizures declined for those taking the high dose of the drug at 46 percent and 49 percent for those taking the lowest dose of the drug, compared with 27 percent of those taking the placebo.
Total seizures reduced by 47 percent for those in the high dose group, 56 percent for those in the lower dose group and 30 percent for those in the placebo group. In the high dose group, 49 percent of participants had their seizures cut by half or more, compared with 44 percent in the low dose group and 26 percent in the placebo group.
All groups reported side effects, with 90 percent of the high-dose group, 88 percent of the low-dose group, and 89 percent of the placebo group. The most common side effects were decreased appetite, diarrhea, drowsiness, fever, and fatigue. About 25 percent of the people in the high-dose group had serious side effects, compared with 20 percent of those in the low-dose group and 15 percent of those in the placebo group. Only the participants in the high-dose group stopped taking the drug because of side effects; this number was 7 percent.
"Based on these results, dose increases above 10 mg / kg per day should be carefully considered based on efficacy and safety for each individual," said Miller.
The study was supported by GW Research Ltd, developer of cannabidiol. In the United States, GW operates through its affiliate, Greenwich Biosciences, Inc.
Learn more about epilepsy at BrainandLife.org, home to the free magazine for patients and caregivers at the American Academy of Neurology, focused on the intersection of neurological diseases and brain health. Follow Brain & Life® on Facebook, Twitter and Instagram.
The American Academy of Neurology is the world's largest association of neurologists and neuroscience professionals with more than 36,000 members. The AAN is dedicated to delivering patient-centered neurological care of the highest quality. A neurologist is a physician with specialized training in diagnosing, treating and managing disorders of the brain and nervous system, such as Alzheimer's disease, stroke, migraine, multiple sclerosis, concussion, Parkinson's disease and epilepsy.
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