Patients with severe epilepsy who took a liquid form of a marijuana extract saw the number of seizures decline by half, while few suffered side effects, according to the early results of a study led by a renowned neurologist at Saint Barnabas Medical Center.
The developments are sure to be followed closely by a number of New Jersey families whose children have Dravet syndrome, a potentially deadly form of epilepsy, and have seen Colorado strains help hundreds of kids. Parents here are buying dried cannabis from one of the three state-sanctioned medical marijuana dispensaries and manufacturing their own cannabis oil.
The study involved 213 people ranging in age from 2 to 26 who are diagnosed with debilitating seizure disorders and for whom other forms of treatment had failed, according to an April 13 announcement from American Academy of Neurology. Each took liquid cannabidiol, an active ingredient in marijuana that does not produce a “high” or euphoric sensation, as part of an “open-label” study designed to determine whether the drug’s safety and side effects.
Out of that group, 137 patients took a daily dose for 12 weeks to see if cannabidiol reduced the frequency of their seizures. The number of seizures decreased by an average of 54 percent after 12 weeks.
The results are promising and lay the groundwork for the next phase of more rigorous placebo-controlled, double-blind trials, which began within the last month, study author Orrin Devinsky said, director of New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center.
“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.”
A total of 12 people stopped taking the drug due to side effects, which included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent), according to the announcement. The median age of the study participant was 11 years old.
The results were shared at the American Academy of Neurology’s annual meeting in Washington D.C last week, Devinsky said.
“Our preliminary data suggest that randomized controlled trials are warranted and we are pleased to report these are now ongoing,” according to a synopsis of the study presented at the meeting.
In 2013, the U.S. Food and Drug Administration gave Devinsky, Roberta Cilio of the University of California – San Francisco’s Neurology Department, and GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, Epidiolex, in a clinical trial with children with seizure disorders, such as Dravet syndrome and Lennox-Gastaut syndrome, incurable forms of epilepsy that lead to lifelong intellectual disabilities.
GW Pharmaceuticals paid for the open-label study, according to the announcement. In 2013, the FDA gave Epidiolex “orphan drug” status and provided GW full marketing rights to be the lone producer of the product for seven years, according to the company. Orphan diseases are rare, occurring in less than 200,000 of people in the nation. There are 5,440 documented cases of Dravet syndrome in the United States and 6,710 in Europe.
Dravet syndrome sufferers in the study saw a 53 percent decline in seizures; people with Lennox-Gastaut syndrome saw a 55 percent reduction, according to the study.
Many families have not waited for clinical trials because their children are so sick and at risk of dying. Inspired by anecdotal reports of the hundreds of children in Colorado who are gaining seizure control using different strains of marijuana, parents are sharing recipes online, although most say they are seeing success with strains that contain some THC, the active ingredient that produces the high most associated with the drug.