Nebraska clinical trial shows cannabidiol benefits
LINCOLN, Neb. (AP) — Most epilepsy patients taking cannabis-derived oil in a clinical trial at the University of Nebraska Medical Center continue to see improvement in their seizures.
The study, authorized by Nebraska lawmakers in 2015, showed that the majority of the 23 participating patients have experienced benefits from taking cannabidiol, commonly referred to as CBD oil. The Legislature approved the clinical trial the same year lawmakers rejected a bill to legalize medical cannabis for a variety of illnesses and conditions
Patients participating in the two-year trial have forms of epilepsy that do not respond to regular treatments. Eleven patients in the study are under 19 years old.
Christopher Kratochvil, UNMC’s associate vice chancellor for clinical research, said the patients who saw the greatest improvement have two of the most difficult forms of epilepsy to treat. Lennox-Gastaut syndrome is a severe form of epilepsy that begins in childhood and produces multiple types of seizures and intellectual disability. Dravet syndrome is a rare, lifelong form of epilepsy that begins in the first year of life with frequent or prolonged seizures.
The drug used in the study is the Epidiolex oral solution, a product approved in June by the federal Food and Drug Administration. The drug is extracted from a compound of the plant that doesn’t produce a high. According to a university report on the clinical study, the federal agency is rescheduling the drug before making it commercially available.
Four patients withdrew from the trial because of bad side effects or limited improvement.
Side effects included sleepiness, unsteady gait, lethargy and a drop in blood platelet count. The side effects could generally be resolved by adjusting the drug’s dosages or other seizure medications, Kratochvil said.
He said the university’s medical center will have more difficulty getting the drug, estimated to cost $32, 000 annually, once it’s made commercially available.