Key News in Family Medicine May 01, 2019 (7 of 8)

By taking a pharmaceutical formulation of Cannabidiol, a cannabis-based drug, epileptic seizures have almost halved in children with a rare and serious epilepsy syndrome called Dravet's syndrome. , according to a Phase 3 study published today and presented at the American Academy of Neurology. 71st annual meeting in Philadelphia, Pennsylvania, May 4-10, 2019. Dravet syndrome, which begins in early childhood, can lead to intellectual disability and frequent, prolonged seizures. 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 to children with this debilitating form of epilepsy and their families," said Ian Miller, MD, author of the study, of Nicklaus Children's Hospital, formerly Miami Children's Hospital, in 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 (average of 9 years old) divided into three groups. One group received 20 milligrams per kilogram (mg / kg) per day of cannabidiol, the second group, 10 mg / kg per day and the third group, a placebo.

Seizures were recorded for 4 weeks before treatment started to establish a baseline. Then, participants received treatment for 14 weeks. At the end of the study, convulsive seizures decreased by 46% for those taking the high dose and 49% for those taking the lowest dose, compared to 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, seizures were reduced by half or more in 49% of participants compared to 44% in the low-dose group and 26% in the placebo group.

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

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

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