Epilepsy and other neurological conditions have been studied and hotly debated for a number of years. In June 2018, the U.S. Food & Drug Administration (FDA) approved Epidiolex®, which is a plant-based cannabidiol (CBD) oral solution for the treatment of seizures associated with two epilepsy syndromes–Lennox-Gastaut syndrome (LGS) and Dravet syndrome–in people two years of age or older. This new medication is the first ever FDA-approved medication to treat seizures in Dravet syndrome.
Researchers studied Epidiolex® in controlled clinical trials for a number of years. These gold standards studies used a control group, with some people taking a placebo while others were given CBD at different doses. Researchers did not know who was getting the placebo and who was getting CBD.
In controlled and uncontrolled trials in people with LGS and Dravet syndrome, 689 people were treated with Epidiolex®. 533 people were treated for more than six months and 391 people were treated for more than one year. Other studies included expanded access and compassionate use, where 161 people with Dravet syndrome and LGS were treated with Epidiolex®, including 109 people treated for more than 6 months.
The addition of CBD to a traditional seizure medication decreased the frequency of drop seizures significantly.
All study participants were taking other seizure medications, and the side effects were not severe enough to stop most people from taking the medicine. The most common side effects were sleepiness, decreased appetite, diarrhea, change in liver function, fatigue, malaise, asthenia (weakness or lack of energy), rash, insomnia, sleep disorder, poor quality sleep, and infections. Interestingly, people getting the placebo also reported diarrhea and an upset stomach, which may be due to both products being oil.
Results from Gold Standard Studies
A study recently published in the New England Journal of Medicine showed that the addition of CBD to a traditional seizure medication decreased the frequency of drop seizures significantly in children and adults with LGS.
Another New England Journal of Medicine study, conducted in May 2017, examined the effectiveness of Epidiolex® in people with drug-resistant seizures with Dravet syndrome. This study showed that the use of CBD resulted in a greater decrease in convulsive-seizures than the placebo among people with the Dravet syndrome. However, it also showed that CBD was associated with higher rates of adverse events.
Additional CBD Studies
A number of clinical trials are underway to show the effects of using Epidiolex® in people with Tuberous Sclerosis Complex and Sturge-Weber Syndrome.