This November, United Patients Group is celebrating National Epilepsy Awareness Month. This month has a special significance for us, as cannabis has shown to be very effective in treating various forms of epilepsy, reducing seizures, and improving the quality of life for many epilepsy patients. This month, we are especially dedicated to spreading awareness about cannabis and how it can be used to treat epilepsy.Read more »
We’ve often talked about the much-hyped use of high-CBD oil to treat children with Dravet syndrome, an intractable form of epilepsy. After Dr. Sanjay Gupta aired a special about an extract made from Charlotte’s Web, a popular Colorado strain, a flood of families flocked to the Centennial State to get access to the oil. When the episode aired in August 2013, no scientific studies had been done on the effectiveness (and side-effectiveness) of using CBD oil to treat epilepsy. Two years later, one clinical trial has been completed, and another one is in the works. What have we learned? Let’s take a look at the latest.
Cannabidiol Study Participants Report >50% Reduction in Seizures
Last spring (April 2015), Orrin Devinsky, MD—a professor of neurology, neurosurgery, and psychiatry at the NYU School of Medicine and director of the NYU Comprehensive Epilepsy Center—published a paper summarizing a GW Pharmaceuticals-sponsored, open-label study involving 213 Dravet and Lennox-Gastaut syndrome patients who were given cannabidiol to reduce their seizures. Epilepsy in these patients, ranging in age from two to 26 years old, had previously not responded to traditional treatments.
Of the 137 patients who completed the 12-week study, the number of seizures for those suffering from Dravet Syndrome decreased by an average of 53 percent, and Lennox-Gastaut Syndrome patients experienced a 55 percent reduction in seizures. Ten percent of patients stopped taking the drug due to side effects, which included drowsiness, diarrhea, decreased appetite, and fatigue.
Dr. Devinsky, a Fellow of the American Academy of Neurology, warns that these are early findings and calls for larger, placebo-controlled double-blind trials.
“So far there have been few formal studies on this marijuana extract,” Devinsky says, continuing, “These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures.”
GW Pharmaceuticals Launches Second Phase 3 Clinical Trials of Epidiolex
Also in April 2015, the UK cannabinoid therapy development and commercialization firm GW Pharmaceuticals announced the launch of its second Phase 3 clinical trial of its CBD-based Epidiolex, an investigational liquid therapy used in the treatment of Dravet syndrome. If found effective, Epidiolex could receive FDA approval to treat patients. The company announced it plans to finish recruiting patients for this trial in 2015 and report top-line results in early 2016.
“The start of our second pivotal Phase 3 clinical trial for Epidiolex in the treatment of Dravet syndrome marks another key milestone in our plan to submit a New Drug Application for Epidiolex to the FDA in mid-2016,” states Justin Gover, GW’s Chief Executive Officer, in the press release. “Therapeutic options for patients with Dravet syndrome are limited and GW is committed to bringing Epidiolex to the market as quickly as possible and to offering a new option to address this significant unmet need.”
The clinical trial follows 150 patients through a 14-week comparison of Epidiolex versus placebo to assess the safety and efficacy of Epidiolex as an adjunctive antiepileptic treatment. After the study, patients can continue receiving Epidiolex as part of a long-term open-label extension study.
Proceed With Caution
Desperate families do not have time to wait for clinical trials and FDA approval—they need treatment now. Bonni Goldstein, MD, medical director of Canna-Centers, who prescribes CBD to children with epilepsy, says that she has found CBD oil to be effective for some children, and the side effects, while notable, are nothing compared with the side effects of epilepsy itself.
“If you try it and it is effective, we do know that there will be fewer side effects,” she explained while conducting a seminar on the subject in 2014. She pointed to a slide that listed potential side effects such as increased alertness and better sleep, and also the opposite: drowsiness and fatigue. “But we don’t see on here liver failure, vomiting, ‘child won’t wake up,’ and so on…”
Whenever we talk to parents of Dravet children, we warn them to source the oils carefully. We are hearing success stories from families who work with reputable cannabis oil producers who adjust CBD and THC levels to find the right ratio for each individual patient. A caring oil-maker will tailor the oil to the individual. But unfortunately, unscrupulous oil-makers have led to a proliferation of “snake oil” products masquerading as CBD oil.
Parents who can’t get to a cannabis-legal state are turning to the Internet to buy hemp-extracted CBD oil, which may or may not be medically valid. The FDA recently tested 18 CBD oils and found that seven of them didn’t contain a detectable level of CBD.
“Some of these firms claim that their products contain cannabidiol (CBD). FDA has tested those products and, in some of them, did not detect any CBD,” notes the agency.
This desperation and shortage is a worldwide phenomenon. New Zealand’s Children’s Commissioner, Dr. Russell Wills, whose job is to weigh in on the rights or welfare of children in the country, is working with United in Compassion New Zealand (UICNZ), an advocacy group pushing for research into the therapeutic effects of cannabis-based medicines, and the NZ Drug Foundation in a campaign for broader access to medicinal cannabis.
Dr. Wills has seen desperate and vulnerable families go to “extraordinary lengths to obtain treatments at enormous cost and extreme risk that then aren’t effective.” Parents are not the only ones frustrated with the current situation, he says. “I think doctors are desperate to see patients have access to effective treatments.”
In the Meantime …
We will continue to report on scientific studies of CBD-oil treatments for Dravet syndrome as they are released. If you are the parent of an epileptic child and are considering using cannabinoid medicine, please set up a consultation with us before you purchase anything. Some of the oils available online may be useless or even harmful! We will help you gain better understanding of the best treatment for you child.