Medical marijuana liquid extract may bring hope for children with severe epilepsy

April 13, 2015

Science Daily/American Academy of Neurology (AAN)

A medicinal liquid form of marijuana may show promise as a treatment for children with severe epilepsy that is not responding to other treatments, according to a study released today that will be presented at the American Academy of Neurology's 67th Annual Meeting in Washington, DC, April 18 to 25, 2015.

The study involved 213 people, ranging from toddlers to adults, with a median age of 11 who had severe epilepsy that did not respond to other treatments. Participants had Dravet syndrome and Lennox-Gastaut syndrome, epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy.

The participants were given the drug cannabidiol, a component of marijuana that does not include the psychoactive part of the plant that creates a "high." The drug is a liquid taken daily by mouth. Participants all knew they were receiving the drug in the open-label study, which was designed to determine whether the drug was safe and tolerated well.

Researchers also measured the number of seizures participants had while taking the drug. For the 137 people who completed the 12-week study, the number of seizures decreased by an average of 54 percent from the beginning of the study to the end. Among the 23 people with Dravet syndrome who finished the study, the number of convulsive seizures had gone down by 53 percent by the end of the study. For the 11 people with Lennox-Gastaut syndrome who finished the study, there was a 55 percent reduction in the number of atonic seizures, which cause a sudden loss of muscle tone.

A total of 12 people, or 6 percent, stopped taking the drug due to side effects. Side effects that occurred in more than 10 percent of participants included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent).

Study author Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center and a Fellow of the American Academy of Neurology, said that these are early findings and larger, placebo-controlled, double-blind trials are needed to measure the effectiveness of the drug.

"So far there have been few formal studies on this marijuana extract," Devinsky said. "These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures."

https://www.sciencedaily.com/releases/2015/04/150413183743.htm

Cannabis-based medicine may reduce seizures for children with difficult-to-treat epilepsy

April 30, 2019

Science Daily/American Academy of Neurology

Taking a pharmaceutical formulation of cannabidiol, a cannabis-based medicine, cut seizures nearly in half for children with a rare and severe type of epilepsy called Dravet syndrome, 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. Dravet syndrome, which starts in infancy, 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 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 success and at the time were taking an average of 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. 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 the treatments were started to establish a baseline. Then the participants received the treatment for 14 weeks. By the end of the study, seizures with convulsions had decreased for those taking the high dose of the drug by 46 percent and by 49 percent for those taking the lower dose of the drug, compared to 27 percent for those taking the placebo.

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, 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, 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 stopped taking the drug due to side effects; that number was 7 percent.

"Based on these results, dose increases above 10 mg/kg per day should be carefully considered based on the effectiveness and safety for each individual," Miller said.

https://www.sciencedaily.com/releases/2019/04/190430164219.htm

Compound derived from marijuana may benefit children with epilepsy

November 7, 2018

Science Daily/Wiley

In recent years, cannabinoids -- the active chemicals in medical marijuana -- have been increasingly touted as a potential treatment for a range of neurological and psychiatric disorders. In a Developmental Medicine & Child Neurology review, investigators compare their efficacy with antiepileptic drugs for children with epilepsy.

One cannabinoid, called cannabidiol (CBD), has the most evidence of antiepileptic efficacy and does not have psychoactive effects. There has been little evidence for its use apart from anecdotal reports, until the last year.

The review notes that in three randomized, placebo-controlled, double-blind trials in Dravet syndrome and Lennox-Gastaut syndrome (two forms of childhood epilepsy), CBD produced a 38 percent to 41 percent median reduction in all seizures compared with 13 percent to 19 percent with placebo. Similarly, CBD resulted in a 39 percent to 46 percent responder rate (50 percent convulsive or drop-seizure reduction) compared with 14 percent to 27 percent with placebo. CBD was well tolerated, however sedation, diarrhea, and decreased appetite were frequent.

"Community debate about the use of CBD and access to this antiepileptic therapy has been heated," the authors wrote. "With further trials and greater understanding of its role, the place of CBD in our antiepileptic armamentarium and its impact on comorbidities will become clearer."

https://www.sciencedaily.com/releases/2018/11/181107082534.htm