According to a phase 3 study released today that will be presented at the American Academy of Neurology’s 71st Annual Meeting in Philadelphia, May 4 to 10, 2019, taking a pharmaceutical formulation of cannabidiol cut seizure rates nearly in half for children with a rare and severe type of epilepsy. This is called Dravet syndrome, which starts in infancy, and can lead to intellectual disability and frequent, prolonged seizures. Cannabidiol [CBD] is derived from marijuana that does not include THC, the psychoactive part of the plant that creates a so-called “high.”
“It’s 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 epilepsy drugs with no beneficial effect and at the time were taking on average three additional drugs, so to have this measure of success with cannabidiol is a major victory.”
The study involved 199 children with an average age of 9, who were divided into three groups of equal size. 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.
“It’s exciting to be able to offer another alternative for children with this debilitating form of epilepsy and their families.”
– Ian Miller, Study Author
In order to establish a comparative baseline the number of seizures was recorded for four weeks before the treatments were started. The participants then received the treatment for 14 weeks. By the end of the study, those taking the high dose of the drug showed a decrease in seizures with convulsions by 46 percent and by 49 percent for those taking the lower dose of the drug. In comparison, those taking the placebo showed a reduction in the number of seizures of 27%.
The number of total seizures reduced by 47 percent for those in the high dose group, by 56 percent for those in the lower dose group and by 30 percent for those in the placebo group. In the high dose group, 49 percent of the participants had their seizures cut in half or more, compared to 44 percent in the low dose group and 26 percent in the placebo group.
All of the groups reported side effects, including 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, sleepiness, fever and fatigue. About 25 percent of those in the high dose group had serious side effects, compared to 20 percent of those in the low dose group and 15 percent of those in the placebo group. Only participants in the high dose group, numbering 7% in total stopped taking the drug as a result of these side effects. “Based on these results, dose levels above 10 mg/kg per day should be carefully considered based on the effectiveness and safety for each individual,” Miller said.
This article has been republished from materials provided by the American Academy of Neurology. Note: material may have been edited for length and content. For further information, please contact the cited source.