By Veronica Volk
The Investigational New Drug is called Epidiolex, and it's different from medical marijuana available through the state's dispensaries. It's almost pure Cannabidiol, which is a chemical compound in cannabis thought to help reduce seizures.
Currently, URMC is involved in an FDA-approved double blind study to test the effectiveness of the drug, the results of which should be available in about a year.
Researchers are now planning for another study, called a Compassionate Use Study, to test the side effects of Epidiolex, and how it reacts with other medications. This study will involved children and young adults.
Doctor David Wang is leading the research at URMC, where he's an Associate Professor of Neurology and Pediatrics. He says patients age one-to-21 with severe, treatment-resistant epilepsy will be eligible to participate.
"Which is defined as, you have used four conventional seizure medications and failed, and you have to have more than eight countable seizures per month."
Patients may be referred to the study by their physicians. Because of the high level of interest for this treatment, eligible participants will be selected through a lottery.
Wang says they were motivated to participate in the study for several reasons. For one, they were approached about the trials for this drug before the Compassionate Care Act went into effect.
"We didn't know medical marijuana use would be legalized at that time, so this was the conduit for our patients to receive this compound."
Wang says they were eager to contribute to the body of scientific knowledge about the effectiveness of cannabis-based medicine. It also came down to money: GW Pharmaceuticals, the drug's developer, is providing Epidiolex for free.
URMC is one of five hospitals across the state participating in this clinical trial.
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