Use of Hemp Based Nutraceuticals as an Adjunctive Agent in Dogs with Epilepsy

The University of Florida College of Veterinary Medicine is currently recruiting dogs with refractory epilepsy for a clinical research trial.  This investigational trial is to determine if a specific hemp based nutraceutical has any effect on the blood concentrations of the drugs that your dog is currently on and if this hemp based nutraceutical has the ability to decrease the number or duration of seizures based on a diary that you keep chronicling your dog’s daily seizures.

Enrollment Status: Closed

• Inclusion Criteria:  Any dog with refractory epilepsy who has been treated with standard medications for at least three months. More specific inclusion criteria will be discussed with you during your pet’s evaluation.
• Treatment: This kind of study is known as a “cross-over study” where participants will receive either the study treatment (hemp based nutraceutical oil) or a placebo oil. A placebo is a medication that looks like the study medication, but does not contain the active ingredient. Participants will receive one of the oils every 12 hours (twice a day treatment every day). The placebo oil should not affect participating dogs in any way, and the study treatment is expected to decrease the seizure episodes. Each of the oils will be given for 3 months in a random order assigned to your dog. During this study period, participating dogs will be required to come in for multiple visits and owners are expected to update the doctors regarding the seizure diary. Dogs will have blood drawn for routine blood tests like blood cell counts and serum chemistries. Study participants will continue their previously prescribed anti-seizure medications regimen throughout the study period, and serum concentrations of these medications will be monitored periodically.
• Costs: The study will cover the cost of the all of the bloodwork and office visits.No other diagnostic testing, imaging or procedures will be covered by the study. All placebo oils and hemp based nutraceutical oils will be free of charge for the duration of the study. If your dog’s seizures subside during the trial the oil that is being tested is commercially available for your purchase after the study.
• Contact: You can contact our Small Animal Hospital Neurology Service at  352 392 2235.
• Principal Investigator: Dr. Gabriel A. Garcia

Background:

Current therapy for controlling seizures in the dog has been a combination of drugs including zonisamide, phenobarbital, levetiracetam (Keppra) and/or potassium bromide. Prior studies in dogs showing safety of oral hemp extracts and the recent FDA approval of Epidiolex, an anti-epileptic consisting of hemp-derived cannabidiol has provided early evidence that hemp based cannabinoid rich extracts could be useful in dogs.