The numbers tell us that about one in every 100 children have recurring epileptic seizures – episodes of electrical misfires that take over the brain, leaving them unable to control their bodies and interrupting thinking and behavior.
For most of them, there are effective treatment options. But for a small yet significant number of children, current treatment doesn’t work. Many of their families have tried different diets, dozens of medicines and sometimes drastic surgeries to remove the epileptic zone of their children’s brains — all in the hope they could stop the seizures, each of which causes loss of cognitive function. Some children are having multiple seizures a day.
Last year, through a public-private partnership involving the state of Georgia; GW Pharmaceuticals, a United Kingdom-based company, and Georgia Regents University, the Georgia Cannabidiol Study began at the Children’s Hospital of Georgia. Children are being enrolled at Children’s Hospital and at study partner sites in Atlanta and Savannah for an expanded 50-person trial.
GW Pharmaceuticals has spent a decade sponsoring and publishing cannabidiol research. Their drug, the cannabis-derived oil Epidiolex, has been studied at 19 U.S. sites involving more than 300 children.
It’s important to note cannabis-derived oil is not medical marijuana, which is typically a dried form of the marijuana plant administered by smoke or vapors, or added to foods or drinks. Medical marijuana contains all components of the marijuana plant, including cannabidiol, THC and many other compounds.
Epidiolex contains only trace amounts of THC and has over 99 percent cannabidiol, which likely does not have the same psychoactive effects that THC causes. Our understanding of how effective cannabidiol will be on children with medication-resistant epilepsy continues to evolve, but there is much work to be done.
What we know is that cannabidiol, one of more than 100 compounds found in the cannabis plant, contains cannabinoids. Those are a family of complex chemicals that lock onto various receptors in the body and may be effective in helping to control brain and nerve activity. While studies in animal models have shown it works as an anticonvulsant, evidence of the same effect in humans had been mostly anecdotal.
That’s why clinical trials — or research studies like this that explore whether a medical strategy, treatment or device is safe and effective for humans — are important. The purpose of clinical trials is research, so the studies follow strict scientific standards that protect patients and help produce reliable study results. Those results typically reveal whether a new medical strategy improves patient outcomes, offers no benefit or causes unexpected harm.
All these results are important because they advance medical knowledge and ultimately improve people’s lives through improved patient care. We owe it to these children and their families to be meticulous in our work and confident in the results — whatever they may be.
To date, 38 Georgia children have enrolled in the Georgia Cannabidiol trial. There are also ongoing trials investigating the effect of cannabinoids in wide-ranging neurological conditions, including spinal cord injury, motor neuron disease, dementia, muscular dystrophy and Dravet syndrome/Lennox-Gastaut syndrome. The hope is that these trials will help develop clear guidelines for the medically sound use of cannabidiol.
For more information about the Georgia Cannabidiol Study, visit www.gru.edu/research/studies/cannabidiol/index.php.
Dr. Yong Park is director of the Pediatric Epilepsy Program at Children’s Hospital of Georgia and professor of neurology and pediatrics at GRU’s Medical College of Georgia. He is the principal investigator on the Epidiolex clinical trials.
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