Cannabis-based drugs can reduce seizures in children with difficult-to-treat epilepsy

PHILADELPHIA – Taking a pharmaceutical formulation of cannabidiol, a cannabis-based drug, has halved seizures in children with a type of rare and serious epilepsy called seizure syndrome. Dravet, according to a Phase 3 study published today that will be presented at the American Academy's 71st Annual Neurology Congress held in Philadelphia from May 4 to 10, 2019. Dravet's syndrome, which starts in the small 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" effect.

"It's exciting to be able to offer another alternative to children with this debilitating form of epilepsy and their families," said Ian Miller, MD, author of the study, Nicklaus Children's Hospital, formerly called Miami Children's Hospital, Florida. "The children in this study had tried an average of four medications for epilepsy unsuccessfully and at the time were taking three more medications on average, and having this measure of success with cannabidiol is a major victory."

The study involved 199 children aged 9 years on average 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 treatment started in order to establish a baseline. Then, participants received treatment for 14 weeks. By the end of the study, convulsive seizures had decreased by 46% for people taking the high dose of the drug and 49% for those taking the lowest dose of the drug, versus 27% for those taking the placebo.

Total seizures were reduced by 47% for patients in the high dose group, 56% for the lowest dose group and 30% for the placebo group. In the high-dose group, 49% of participants had fewer seizures or more, compared to 44% in the low-dose group and 26% in the placebo group.

All groups reported adverse events, with 90% of the high-dose group, 88% of the low-dose group and 89% of the placebo-treated group. The most common side effects were decreased appetite, diarrhea, drowsiness, fever and fatigue. Approximately 25% of patients in the high-dose group experienced serious adverse events, compared to 20% of patients in the low-dose group and 15% of those in the placebo group. Only participants in the high-dose group stopped taking the drug because of side effects; this number was 7 percent.

"Based on these findings, dose increases greater than 10 mg / kg per day should be carefully considered based on the efficacy and safety for each individual," Miller said.

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The study was funded by GW Research Ltd, developer of cannabidiol. In the United States, GW operates through its subsidiary, Greenwich Biosciences, Inc.

To learn more about epilepsy, visit BrainandLife.org, site of the free magazine for patients and caregivers of the American Academy of Neurology, dedicated to the intersection of neurological diseases and health of the brain. Follow Brain & Life® on Facebook, Twitter and Instagram.

The American Academy of Neurology is the world's largest badociation of neuroscientists and neuroscience professionals, with more than 36,000 members. AAN is dedicated to promoting patient-centered neurological care of the highest quality. A neurologist is a physician with specialized training in the diagnosis, treatment, and management of brain and nervous system disorders such as Alzheimer's disease, stroke, migraine, multiple sclerosis, osteoarthritis. concussion, Parkinson's disease and epilepsy.

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