Article by Watertown Daily Times Story by Eli Anderson
The state Department of Health will soon begin studying the effects of medical cannabis on children and young adults with severe epilepsy.
The Department announced Monday that it will be testing Epidiolex, an investigational pharmaceutical-grade form of cannabidiol, at the following sites: University of Rochester Medical Center; Women and Children’s Hospital of Buffalo; Montefiore Medical Center, the Bronx; Mouth Sinai Beth Israel and New York Langone Medical Center, both of New York City.
The study will focus on patients between the ages of 1 and 21 who meet a clinical definition of severe, treatment-resistant epilepsy. Children and young adults will be referred by their treating neurologist for consideration as participants and initial enrollment of selected patients is expected to begin in the next few months.
“Given the devastating effects seizures have on development and the quality of life for these children and young adults, we are thrilled to be able to provide this opportunity to patients who may qualify,” Health Commissioner Dr. Howard A. Zucker said in a news release. “These studies will give patients in New York State who are not responding to conventional anti-epileptic therapy access to a drug that has shown promise in previous expanded access studies.”
The studies, which are approved by the U.S. Food and Drug Administration, will last one year. Epidiolex is not FDA-approved, however, and is thus not currently available to New York State patients outside of clinic trials.
DOH is currently notifying New York State neurologists of the studies and providing further guidance on the referral process.
Data gathered from the studies will contribute to the knowledge of the safety and tolerability of Epidiolex in young people with intractable epilepsy and will expand the number of practitioners with experience in providing the drug.
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