Doctor hopes medical marijuana clinical trials could make pot Schedule II

Dr. Paul Lyons says results are positive when Epidiolex is used for epilepsy

WINCHESTER, Va. - Phase one of a clinical trial testing medical canabinoids to treat epilepsy is complete, and the doctor who conducted the trial has released some of his findings at a symposium hosted by the Winchester Neurological Consultants.

"We've had a significant reduction in number of seizures, severity of seizures and increase in the number of seizure-free days, and just as importantly, improvement in cognition," said Dr. Paul Lyons, an epileptologist at Winchester Neurological Consultants.

For the last four months, Lyons has been conducting the double-blind experiment with a test group of 14 children who have severe LGS epilepsy.

During that time, no one, including Lyons and the children's' parents, knew which subjects were taking 20mg per kg of body mass of Epidiolex twice a day, and which had been taking a placebo.

Tonya Viands' 11-year-old son Jaden received the medication, and he was walking happily next to his mother before she spoke to the group about Jaden's success.

But four months ago, walking was out of the question for Jaden.

"[Epidiolex] literally brought my son back to life - it really did," Viands said. "He just kind of sat in the chair and drooled. He didn't have any interest in anything. It literally brought him back to life."

Epidiolex is very different from medical marijuana because its levels of THC, or the compound that makes you feel "high," are very minimal. The drug is a liquid, so it is injected into the mouth and not smoked like traditional medical marijuana.

Viands said Epidiolex saved Jaden from a life of pain.

"Severe seizures, drop attacks, drop seizures where they hit the floor. He was having up to 15 [seizures] a day with broken noses, broken collar bones."

Thanks to the clinical research, Viands said Jaden is now only having three seizures a day in his sleep. 

Viands said Jaden is also able to attend school more regularly, having only missed 10 days this school year for the clinical testing, opposed to 86 last year for seizures and medical problems related to his epilepsy.

According to Dr. Lyons, the implications of the data collected could have a major influence at the federal level.

"The FDA requirement of valid clinical data is now being acquired, which means that the FDA could have the information that there is clinical utility to medical canabinoids," he said.

"I hope that this would move the dialogue on the medical indication for medical canabinoids in the U.S. and clearly distinguish that from the recreational use," Lyons said. "In that way, the federal government, through the FDA and the DEA, could be the leaders on establishing logical, rational and readily available research for these kinds of diseases so patients don't have to wait years for clinical trials as they did with this case."

Lyons said the 15 families that enrolled to be part of the trial waited two years to get medical canbinoid treatment for epilepsy - medical marijuana is not legal in their home states

Right now, only 24 states and D.C. have legalized medical canabinoids, and if you don't live in one of those states, the only way to get medical canabinoid treatment is through clinical research.

Viands came to Virginia from Martinsburg to seek help for Jaden after she said the ketogenic diet caused him to lose 6 pounds in 10 days and none of the epilepsy medication worked.

"This was the last resort before brain surgery," she said.

According to Lyons, the burden of epilepsy falls on the entire family, and parents like Viands are the true champions for care that actually works.

"I really think that they are heroes of delivering superlative care with very few resources without any notoriety, without any praise."

Now, the 14 families that continued with the trial in its first phase are moving on to the "open label" phase, which allows their children to continue taking Epidiolex.

Lyons said he will begin to increase the dosages by 30mg per kg of body mass. 


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