The long-term administration of cannabis-plant derived extracts containing a 50 to 1 ratio of CBD to THC is safe and effective in children with treatment-resistant epilepsy, according to clinical trial data published in the journal Annals of Clinical and Translational Neurology.
Canadian researchers assessed the adjunctive use of a proprietary CBD/THC extract (aka TIL-TC150, manufactured by Tilray Inc.) over a 20-week period in children with Dravet syndrome. Investigators reported that the treatment was “safe and well tolerated,” and was associated with reduced seizure frequency and improvements in quality of life measures.
They concluded: “To our knowledge, this study is the first of its kind to examine with rigor the dosing and tolerability of a mixed cannabinoid product containing both CBD and THC in children with DRE (drug-resistant epilepsy). … Our study adds to a growing body of evidence that cannabinoids exert anti-seizure effects and are safe and tolerable in treating pediatric DRE.”
In June, the US Food and Drug Administration granted market approval to the plant-derived CBD extract Epidiolex for the treatment of pediatric epilepsy.
Last month, investigators associated with the University of California Center for Medicinal Cannabis Research announced that the US DEA had granted them permission to import Tilray’s plant-derived CBD/THC formulations into the United States for use in clinical trials of adults with essential tremor (ET).
Full text of the study, “A prospective open-label trial of a CBD/THC cannabis oil in Dravet syndrome,” appears online.
Tags: Dravet syndrome, Tilray