Phase 2 CBD Clinical Trial—Pilot Epilepsy Study
Once a Phase 1 trial has determined that a treatment is safe, researchers can begin with Phase 2 trials to look at efficacy. In other words, a Phase 2 trial seeks to answer the question: Does this treatment work? After the successful conclusion of the Phase 1 safety trial, Dr. McGrath and her colleagues at CSU launched a Phase 2 trial to study the use of CBD oil in dogs with epilepsy.
For this pilot epilepsy study, researchers initially enrolled twenty six dogs with intractable idiopathic epilepsy. After exclusions, sixteen dogs completed the 12-week double-blind trial. Dogs were randomly assigned to a CBD group or placebo group, with the CBD group receiving ABSC’s CBD-infused oil twice daily for 12 weeks while continuing their existing anti-epileptic treatments. The placebo group received oil without CBD, and also continued their existing medications. All other parameters were consistent for both groups.
Dr. McGrath and her colleagues at CSU compared seizure activity, adverse effects, and plasma CBD concentrations over the course of the twelve weeks, and found that 89% of the dogs in the CBD group saw a reduction in seizure frequency. Researchers also found a strong correlation between plasma (blood) CBD concentration and reduced seizure frequency.2 Results from this study were published in the June 1, 2019 issue of the Journal of the American Veterinary Association.2
Based on the exciting results from the pilot study at CSU, the American Kennel Club’s Canine Health Foundation has sponsored a larger study with Dr. McGrath to further study the effects of Cannabidiol on canine epilepsy.11