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Cannabidiol a marijuana extract could be useful in reducing seizure rates in Dravet patients

27 May, 2017

Although it looks promising, cannabidiol is hard to study in the United States because marijuana is still classified as a schedule 1 drug ("no now accepted medical use and a high potential for abuse"). Earlier trials on epilepsy, for instance, were small or suboptimal and provided mixed results. Unlike tetrahydrocannabinol (THC) though, Cannabidiol is not psychoactive, but there are still some side effects for children under 10 years old (the age of those in the study).

Dravet syndrome is a rare but severe form of epilepsy that usually occurs in a child's first year of life and often develops into intractable epilepsy later in life.

Dravet syndrome normally appears in the first year of life. This gene is critical for proper electrical signaling in the brain because it contributes to voltage-gated sodium ion channels in neurons.

Australian doctors were part of an global trial, testing a component of medicinal cannabis known as cannabidiol in kids with Dravet syndrome. There were 976 responses, about 60 percent from adults with epilepsy and the remainder from children with epilepsy.

There is no specific or Food and Drug Administration-approved treatment for Dravet syndrome despite anecdotal stories of cannabis products treating other epilepsy disorders. The primary endpoint was the change in convulsive-seizure frequency over 14 weeks, compared with a 4-week baseline period.

The difference in the degree of seizure reduction between the CBD group and the placebo group was both statistically significant and clinically consistent, according to the researchers.

With cannabidiol, the median frequency of convulsive seizures per month decreased from 12.4-to-5.9, compared to a decrease from 14.9-to-14.1 with placebo.

Professor Scheffer said other Australian groups were trialling medicinal cannabis, mainly in open-label trials where patients know if they are getting the drug or the placebo.

The Figis treated their daughter with a specially prepared CBD-containing oil, now known as Charlotte's Web, which is derived from hemp, a type of cannabis containing less than 0.3 percent THC by weight. Three of the participants taking CBD became completely free of seizures, but none in the placebo group did.

The participants also reported feeling better overall.

But these benefits had costs. And three people taking CBD stopped having seizures altogether. A total of 93% of the patients taking the drug experienced a side effect, though most were mild or moderate.

On the safety side, Epidiolex was generally well tolerated in the trial, the the most common adverse events (AEs) found to be somnolence, diarrhoea, decreased appetite, fatigue, vomiting, pyrexia, lethargy, convulsion, upper respiratory tract infection.

Sixty-one patients were randomly assigned to cannabidiol, and the 59 others to placebo. They also relate four case studies of pediatric epilepsy patients that illustrate the complexities of treatment due to variability of these preparations.

But CBD, Devinsky says, is still far better than current treatments available: "Interestingly numerous side effects probably came from the oil and not from the medication". "They are subject to many forms of bias". GW Pharmaceuticals - which paid for the clinical trial - expects to file for FDA approval of the drug this year. "This bill paves the way for new research to be conducted with greater ease to determine if cannabidiol can be an effective medication for serious illnesses such as intractable epilepsy".