PHILADELPHIA – Doing a pharmaceutical formulation of cannabidiol, a cannabis-based drug, reduces seizures by almost half for children with a rare and severe type of epilepsy called Dravet syndrome, according to a Phase 3 study published today which will be presented at the American Academy of the 71st Annual Neurology Meeting in Philadelphia from May 4 to 10, 2019. Dravet's syndrome, which begins in childhood, can lead to intellectual disabilities and prolonged seizures and frequent Cannabidiol is derived from marijuana that does not include the psychoactive part of the plant that creates a "high".
"It's exciting to be able to offer another alternative for children with this form of epilepsy and their families," said author of the Ian Miller, MD study at the Nicklaus Children's Hospital, formerly Miami Children & # 39; s Hospital in Florida. "The children in this study had already tested an average of four epileptic medications without success and at that time they had an average of three additional medications, so that having this measure of success with cannabidiol is an important victory."
The study had 199 children with an average age of 9 that were divided into three groups. One group received 20 milligrams per kilogram (mg / kg) per cannabidiol day, the second group received 10 mg / kg per day and the third group received a placebo.
Seizures were recorded for four weeks before beginning treatments to establish a baseline. Then, the participants received treatment for 14 weeks. At the end of the study convulsions with seizures had decreased for those who took the high dose of the drug by 46% and 49% for people who took the lowest dose of the drug, compared to 27% of those taking placebo.
Total seizures decreased 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 the participants cut seizures by half or more, compared to 44 percent of the low dose group and 26 percent to the placebo group.
All groups reported side effects, with 90% of the high dose group, 88% of the low dose group and 89% of the placebo group. The most frequent side effects were decreased appetite, diarrhea, somnolence, fever and fatigue. About 25 percent of those who were part of the high dose group had severe side effects, compared to 20 percent of those who formed the low dose group and 15 percent of those in the placebo group. Only participants in the high dose group stopped taking the medication due to side effects; This number was 7 percent.
"Based on these results, the increase in doses above 10 mg / kg per day should be carefully considered according to the efficacy and safety of each individual," Miller said.
The study was supported by GW Research Ltd, a cannabidiol developer. In the United States, GW operates through its subsidiary, Greenwich Biosciences, Inc.
More information on the epilepsy of BrainandLife.org, the headquarters of the free magazine for patients and carers of the American Academy of Neurology, centered 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 neuroscience neurologists and professionals, with more than 36,000 members. The AAN is dedicated to promoting high quality patient-centered neurological care. A neurologist is a doctor with specialized training in the diagnosis, treatment and management of disorders of the brain and the nervous system, such as Alzheimer's disease, stroke, migraine, multiple sclerosis, the cerebral upset, the Parkinson's disease and the epilepsy.
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