Cannabis derivative cannabidiol reduces seizures in severe epilepsy disorder

May 24, 2017

After years of anecdotal claims about its benefits, the cannabis derivative cannabidiol reduced seizure frequency by 39 percent for patients with Dravet syndrome - a rare, severe form of epilepsy - in the first large-scale randomized clinical trial for the compound. The findings were published online May 24 in the New England Journal of Medicine.

"Cannabidiol should not be viewed as a panacea for epilepsy, but for patients with especially severe forms who have not responded to numerous medications, these results provide hope that we may soon have another treatment option," says lead investigator Orrin Devinsky, MD, professor of neurology, neurosurgery, and psychiatry and director of the Comprehensive Epilepsy Center at NYU Langone Medical Center. "We still need more research, but this new trial provides more evidence than we have ever had of cannabidiol's effectiveness as a medication for treatment-resistant epilepsy."

Cannabidiol, or CBD, is a compound in the cannabis plant that does not contain psychoactive properties that induce a high. The study included a liquid pharmaceutical formulation of CBD, called Epidiolex, which is manufactured by GW Pharmaceuticals and has not been approved by the U.S. Food and Drug Administration. GW Pharmaceuticals funded the clinical trial.

For the study, 120 children and adolescents with Dravet Syndrome between the ages of 2 and 18 years were randomized across 23 sites in the United States and Europe to receive either CBD 20 mg/kg or placebo added to their existing treatment over a 14-week period. Seizure frequency was tracked for one month prior to the study for baseline readings, and during the course of the study.

Specifically, seizure frequency dropped in the CBD-treated group by 39 percent from a median of nearly 12 convulsive seizures per month before the study to about six; three patients' seizures stopped entirely. In the placebo group, there was a 13 percent reduction in seizures from about 15 monthly seizures to fourteen. The difference in the degree of seizure reduction between the CBD group and the placebo group was both statistically significant and clinically consistent.

Side effects - experienced by 93.4 percent of patients in the CBD group and 74.6 percent of those treated with placebo - were generally reported as mild or moderate in severity. The most common side effects in the CBD group were vomiting, fatigue and fever. Eight participants from the CBD group withdrew from the trial due to side effects compared to one participant in the placebo group.

The new study confirms results from a December 2015 open-label expanded access program led by Dr. Devinsky that reported reductions in seizure frequency. In that program, both the researchers and patient's families knew they were receiving CBD, which may have introduced a bias into the results.

This new, randomized, controlled clinical study eliminated those concerns as participants and their physicians did not know if they were on CBD or placebo, say the study authors.

Future research will look at whether safety and tolerability might be improved and whether efficacy of CBD can be maintained at lower doses. Longer term studies of CBD for Dravet Syndrome as well as for other forms of treatment-resistant epilepsy are also underway.
-end-
In addition to Dr. Devinsky, the co-authors in this study were: J. Helen Cross, PhD, FRCPCH, Linda Laux, MD, Eric Marsh, MD, Ian Miller, MD, Rima Nabbout, MD, Ingrid E Scheffer, MD, PhD , Elizabeth Thiele, MD, and Stephen Wright, MD on behalf of The Cannabidiol in Dravet Syndrome Study Group. Judith Bluvstein, MD, and Daniel Friedman, MD, also served as co-authors at the NYU Langone site involved in the study.

NYU Langone Medical Center / New York University School of Medicine

Related Epilepsy Articles from Brightsurf:

Focal epilepsy often overlooked
Having subtler symptoms, a form of epilepsy that affects only one part of the brain often goes undiagnosed long enough to cause unexpected seizures that contribute to car crashes, a new study finds.

Antibodies in the brain trigger epilepsy
Certain forms of epilepsy are accompanied by inflammation of important brain regions.

Breaching the brain's defense causes epilepsy
Epileptic seizures can happen to anyone. But how do they occur and what initiates such a rapid response?

Using connectomics to understand epilepsy
Abnormalities in structural brain networks and how brain regions communicate may underlie a variety of disorders, including epilepsy, which is one focus of a two-part Special Issue on the Brain Connectome in Brain Connectivity, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.

Epilepsy: Triangular relationship in the brain
When an epileptic seizure occurs in the brain, the nerve cells lose their usual pattern and fire in a very fast rhythm.

How concussions may lead to epilepsy
Researchers have identified a cellular response to repeated concussions that may contribute to seizures in mice like those observed following traumatic brain injury in humans.

Understanding epilepsy in pediatric tumors
A KAIST research team led by Professor Jeong Ho Lee of the Graduate School of Medical Science and Engineering has recently identified a neuronal BRAF somatic mutation that causes intrinsic epileptogenicity in pediatric brain tumors.

Can medical marijuana help treat intractable epilepsy?
A new British Journal of Clinical Pharmacology review examines the potential of medicinal cannabis -- or medical marijuana -- for helping patients with intractable epilepsy, in which seizures fail to come under control with standard anticonvulsant treatment.

Fertility rates no different for women with epilepsy
'Myth-busting' study among women with no history of infertility finds that those with epilepsy are just as likely to become pregnant as those without.

Do women with epilepsy have similar likelihood of pregnancy?
Women with epilepsy without a history of infertility or related disorders who wanted to become pregnant were about as likely as their peers without epilepsy to become pregnant.

Read More: Epilepsy News and Epilepsy Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.