General Information

 

PARTICIPATION IN THIS CLINICAL TRIAL REQUIRES VISITS TO COLORADO STATE UNIVERSITY EVERY 4 WEEKS FOR 12 WEEKS
 
Background and purpose of the trial:

Epilepsy is currently reported to affect approximately 5% of the canine population; of that number approximately 30% of dogs are poorly controlled on routine anti-epileptic drugs (AEDs). Recent CBD research has demonstrated the anti-convulsive properties in both canine and human patients; however, to-date a dose finding study has not been performed in veterinary patients. For the initial phase of this study, our primary purpose is to determine a dose of CBD that will reduce the seizure frequency in canine patients to 50% or less.

Who qualifies:

Dogs who have experienced at least 2 generalized seizures per month for 3 consecutive months after being treated with at least one routine AED, including: phenobarbital, potassium bromide, levetiracetam (Keppra), and/ or Zonisamide. All dogs must be otherwise healthy with no indication of neurologic disease that may be the cause of seizures. Dogs with pre-existing liver disease or any type of cancer will be excluded. If a dog is taking CBD prior to enrollment, the CBD treatment must be discontinued at least 4 weeks prior to the initial appointment.

Study Design:

Once it has been verified that initial criteria have been met, dogs will come to CSU to have a neurologic examination, undergo an MRI and CSF tap, and have bloodwork performed, including AED levels, to rule out any obvious causes of epilepsy. At this visit we will also check a CBD level to ensure there’s no current CBD in the system. If a dog has already had an MRI and CSF tap performed recently it will not be necessary to repeat. After the MRI and CSF tap, each dog will be randomly assigned to one of three dosing groups: 5mg/kg, 10mg/kg, or 20mg/kg given twice daily. Over the next 12 weeks, you will bring your dog to CSU for a recheck examination, routine bloodwork, and a CBD level every 4 weeks. Additionally, at the 12-week time point, all dogs will have a neurological examination performed and AED levels checked.

Commitment:

During the 12 week study you are unable to make any changes to your dog’s medications so it’s crucial that you’re comfortable with his or her current medication protocol prior to enrolling. You will be committed to bringing your dog back to CSU every 4 weeks for the 3 month study period so that we can obtain blood samples. You will also be committed to filling out a standardized monthly seizure log as necessary along with a weekly behavior survey.

Incentives:

All exams and diagnostic testing, including the monthly bloodwork, will be covered by the study. In addition you will receive a $300 credit to your VTH account split into 3 payments dispersed after each successful recheck appointment.
 
If you have any questions regarding the clinical trial please contact Breonna Kusick at CSUNeuroTrials@colostate.edu or 970-297-4405
 
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