Following a rigorous review process, the trial is being conducted by the University of Mississippi Medical Center and the UM School of Pharmacy on UMMCâ€™s Jackson campus.
The studyâ€™s focus is to determine the safety and tolerability of the medication for children with severe epilepsy whose seizures are uncontrolled by other means, said principal investigator Dr. Brad Ingram, UMMC associate professor of pediatric neurology and director of the Pediatric Comprehensive Epilepsy Program.
Ingram described the six-month trial, which involves 10 patients, as â€ścompassionate careâ€ť for â€śthe sickest of the sick.â€ť
â€śThese 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,â€ť Ingram said.
Required approvals were obtained from the Drug Enforcement Agency and the Food and Drug Administration. The clinically tested investigational drug product is an oral cannabidiol, CBD for short, derived from marijuana grown at the UM School of Pharmacyâ€™s National Center for Natural Products Research.
Dr. Richard Summers, UMMC associate vice chancellor for research, said, â€śApproval of a first phase clinical trial of cannabidiol oil in patients with seizures that are not controlled with conventional treatments is a milestone for our translational research efforts at UMMC. In this study, extracts of a plant grown on the Oxford campus are being practically translated into a potential new therapy for patients who suffer a debilitating illness.â€ť
The oral solution consists of a CBD extract manufactured at NCNPRâ€™s Coy Waller Laboratory, home of the Marijuana Project led by Drs. Mahmoud ElSohly and Ikhlas Khan. 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.
Once the extract is manufactured, packaged and checked to ensure it meets all quality control specifications, it is transferred to the pharmacy at UMMCâ€™s main campus in Jackson. There, the extract is diluted with pharmaceutical-grade sesame seed oil to achieve the proper dosage concentration for administration to patients.
Dr. Larry Walker, director emeritus of the NCNPR, was instrumental in planning the study and in arranging to provide the study materials to UMMC through the National Institute on Drug Abuseâ€™s drug supply program, for which NCNPR is the sole supplier of marijuana and cannabis extract.
Walker said the partnership between NCNPR and UMMC opens the door to progress.
â€śDr. ElSohlyâ€™s team at the NCNPR has worked diligently on the product development, manufacturing, regulatory clearances and other hurdles,â€ť he said. â€śThis promises to be a milestone that could greatly stimulate the national research agenda for developing FDA-approved cannabis-derived drug products.â€ť
This trial will allow a more rigorous scientific, quality-controlled study of the plantâ€™s medicinal use because of the federally regulated consistency of the product, officials said.
The possibility of organizing this clinical trial came about in 2014, when the Mississippi Legislature passed a law allowing the Medical Center to dispense CBD oil for the treatment of epileptic seizures in children.
â€śUMMC is the site for so many firsts,â€ť said Sen. Josh Harkins, R-Flowood, who authored the bill. â€śWeâ€™d like to see this first, a trial of an investigational new drug product developed at the University of Mississippi and tested at the University of Mississippi Medical Center, result in improved treatments for children with epilepsy.â€ť
UMMC press release