JACKSON, Miss. – Results from a clinical trial of a new marijuana-derived drug to treat seizures in children prompted approval of a one-year extension to the study.
The clinically tested investigational drug product is an oral cannabidiol, CBD for short, derived from marijuana grown at the University of Mississippi School of Pharmacy’s National Center for Natural Products Research. To conduct the trial, required approvals were obtained in 2018 from the Drug Enforcement Agency and the Food and Drug Administration.
The extract, a Schedule I controlled substance, is prepared from a special type of marijuana that has a high concentration of CBD and a low concentration of THC, the psychotropic element of marijuana.
The trial, conducted by the University of Mississippi Medical Center and the UM School of Pharmacy, was approved for 10 patients. All patients in the initial trial opted to participate in the extension.
Treatment with the drug, described as “compassionate care for the sickest of the sick” by principal investigator Dr. Brad Ingram was proven to be safe in the trial’s first six months. Those in the trial “are patients whose lives have been devastated by their epilepsy, even up to their abilities to walk, talk, or participate in simple activities of self-care,” Ingram said.
Results so far have shown promise, Ingram said. “Some of the trial participants are at the status quo, and some have had a really good response to the drug. All of the participants, though, seem to have some positive outcome, such as more pleasant mood or sleeping better.