Neurologists at Primary Children’s Hospital are one step closer to being able to prescribe pharmaceutical-grade cannabis to children and teens with severe epilepsy.
Only those who apply to be part of a drug trial will be eligible — 25 spots are available — and it’s not known when the study will start.
The study’s lead author, neurologist Francis Filloux, is waiting for a license from the Drug Enforcement Administration freeing him to handle Schedule 1 substances, said Ed Clark, chief medical officer at Primary Children’s.
Schedule 1 drugs are considered the most dangerous and potentially addictive; the category includes heroin, LSD and marijuana. No doctor or researcher at Primary Children’s or the University of Utah has a Schedule 1 license, Clark said. But he’s confident Filloux will be approved.
“This is a federally approved study. I see no barriers other than bureaucracy,” he said. “We’re very excited to be doing this. Our teams here recognized that this was an emerging need and started to put this study together in 2013.”
It’s an open-label observational trial, which means everyone enrolled will receive Epidiolex, a liquid, purified form of cannabidiol (CBD), a nonpsychoactive chemical in marijuana. Epidiolex is manufactured by British drugmaker GW Pharmaceuticals.
GW Pharmaceuticals and the U.’s Institutional Review Board have approved Primary Children’s as a study site.
The trial will be open to children ages 2 to 17 who have treatment-resistant epilepsy, defined as not responding to at least four anti-epileptic drugs.
The primary goal will be to test the tolerability of Epidiolex and the optimal dose of CBD, a chemical shown to have powerful anti-seizure properties in children who have tried whole-plant marijuana extracts.
Parent activists who pushed for Charlee’s Law — which frees Utahns with epilepsy to import whole-plant CBD extracts from states where medical marijuana is legal — have long hoped Primary Children’s would study Epidiolex.
But the timing of the study poses a challenge for families who are on a waiting list for a highly sought CBD oil made by Colorado Springs growers at the Realm of Caring Foundation.
Those families will be eligible to apply for a Utah “hemp supplement” registration card starting July 8. But taking the oil could exclude them from participating in Primary Children’s study, which has an unknown start date.
“It’s a decision point for families, to do this study or try a whole plant extract,” acknowledged Clark.
Epidiolex is similar but not identical to “artisanal” CBD oils, which contain trace amounts of tetrahydrocannabinol (THC), the chemical in cannabis that gives users a high.
The artisanal oils have been shown to work for patients who have exhausted all other remedies. In an observational