A new study involving 11 epilepsy centers across the United States shows that a purified compound derived from marijuana may help reduce seizures in children and young adults with severe forms of epilepsy who don’t find relief from other treatments.
Cannabidiol, a non-psychoactive substance known as CBD, was found to have reduced seizures by 36.5% among children and young adults receiving treatment at 11 epilepsy centers across the country. The new research involved 137 patients between the ages of one and 30 years old.
Cannabidiol was also well-tolerated and safe, lead author Dr. Orrin Devinsky, professor of neurology, neurosurgery, and psychiatry and director of the Comprehensive Epilepsy Center at NYU Langone Medical Center, said. “We are very encouraged by our trial results showing that CBD was safe and well-tolerated for most patients, and that seizures dropped significantly,” says Devinsky.
“But before we raise hopes for families who regularly deal with the devastation of treatment-resistant epilepsy, more research, including further studies through our ongoing randomized controlled trial, are needed to definitively recommend CBD as a treatment to patients with uncontrolled seizures.”
“These are some of most difficult to control patients in all of our practices,” said Devinsky. Many had not responded to multiple drugs, surgery, and dietary treatments, he added.
The study was an open-labeled trial, meaning that both the researchers and participants’ families knew they were receiving CBD, a compound in medical marijuana that does not contain psychoactive properties.
Between January 15, 2014, and January 15, 2015, 214 patients between 1 and 30 years of age with intractable, or treatment-resistant, epilepsy were enrolled in the trial. Of that cohort, 162 (76 percent) had at least 12 weeks of follow-up after the first dose of CBD and were included in the safety and tolerability analysis. In addition, 137 of the original study cohort (64 percent) were included in the analysis to determine the drug’s efficacy.
The form of CBD used in the new study was a solution of the extract in oil called Epidiolex from GW Pharmaceuticals, which partly funded the new study. The drug is currently being evaluated by the U.S. Food and Drug Administration. “Essentially, there was no THC and only trace amounts of other compounds,” Devinsky said, referring to the psychoactive chemical in marijuana, so the treatment would not give patients a high.
“We know what we’re giving, the exact dose,” he said. “I can’t speak to artisanal products made in many states. Here we used a drug company going through standards.”
Patients logged seizures in diaries, which were reviewed by the study team at each visit. Lab screenings were also conducted at the study’s start and regularly throughout treatment.
Devinsky said there was about a 36.5 percent reduction in monthly motor seizures — the type of seizures that cause muscle jerking or stiffening.
“The medium monthly frequency of motor seizures went from 30 per month at baseline to 15.8 per month over the 12 week treatment period,” Devinsky said. “The findings are very promising.”
But he said before families raise their hopes, more research is needed. Devinsky is currently leading a randomized, controlled trial in which CBD or a placebo is randomly assigned to patients to better tease out the drug’s effects and better eliminate research bias. “I empathize with parents who are looking for answers and will try anything to help their children suffering the devastating effects of intractable epilepsy. But we must let the science, and not anecdotal success stories and high media interest, lead this national discussion,” cautions Devinsky.
Many scientists have complained that tight federal restrictions made it difficult to study the effects of marijuana, even as 23 states have legalized pot for medical use.
“These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies,” the DEA said in a statement.
The 11 sites included in the trial are NYU Langone Medical Center; Children’s Hospital of Philadelphia; Massachusetts General Hospital for Children; Ann & Robert H Lurie Children’s Hospital of Chicago; Benioff Children’s Hospital, University of California, San Francisco; Miami Children’s Hospital; Pediatric and Adolescent Neurodevelopmental Associates in Atlanta; Texas Children’s Hospital; University of Utah Medical Center and Primary Children’s Hospital; Wake Forest School of Medicine; and Nationwide Children’s Hospital.
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