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Comparison of Phenobarbital and Bromide as Sole First Choice Drug Therapy for Treatment of Canine Epilepsy

FUNDED BY THE AKC - CANINE HEALTH FOUNDATION

This Study is no longer accepting patients. 

Thank you for your interest.

What is epilepsy?

The term "epilepsy" refers to recurrent seizures caused by problems originating in the brain. Epilepsy is not a disease, but a clinical sign of a disease affecting the brain.

What causes epilepsy and why does my dog suffer from it?

All of the causes of epilepsy are not known. It is known that recurrent seizures occur when nerve cells in the brain become too excited. If the excitation spreads to other cells in the brain, all parts of the body can be stimulated and the result is a convulsion. Some known causes of epilepsy include:

-injury or disease involving the brain

-tumors

-incorrect brain development

-genetic predisposition of some breeds

How is epilepsy treated?

If an underlying cause for epilepsy, such as a tumor or infection, is identified, then epilepsy is treated by removing the cause. Unfortunately, the cause is seldom identifiable and often untreatable. In these cases, the seizures are treated with drugs known as anticonvulsants. Anticonvulsants act by preventing nerve cells in the brain from becoming too excited. Anticonvulsive drugs can only control epilepsy, not cure it. The goal of anticonvulsive drug therapy is to reduce the frequency and/or severity of the seizure. Every pet's response to therapy will vary, and success of therapy is greatly increased by owner compliance with dosing schedules. Currently, the most effective anticonvulsant used in dogs is phenobarbital..

Can other drugs control my pet's epilepsy?

Several drugs are used to treat epilepsy in people, but studies have shown that phenobarbital is the most likely to control epilepsy in dogs. The intent of this study is to scientifically determine if potassium bromide, also a proven anticonvulsant, will work as well as phenobarbital in controlling canine epilepsy. Why should I participate in this study? The health of your dog should be the primary reason for participating in this study. Each patient included in the study will receive intensive evaluation and care. It is important to realize that nothing will be done to your dog that is not part of normal, recommended regimen for diagnosis and treatment of epilepsy.

How were the drugs for the study selected?

The two drugs, potassium bromide and phenobarbital, were selected for use in this study based on the following:

-clinical cases reporting

-efficacy in controlling seizures and safety to your pet

-investigators' experience with the drugs

-convenience of administration

-cost of the drugs

-availability of therapeutic drug monitoring (measuring drug levels in your pet's blood)

Why should I participate in this study?

The health of your dog should be the primary reason for participating in this study. Each patient included in the study will receive intensive evaluation and care. It is important to realize that nothing will be done to your dog that is not part of normal, recommended regimen for diagnosis and treatment of epilepsy. Click here for patient selection criteria.

What happens after my pet has been selected into the study?

If your pet has been accepted into the study, we will notify your veterinarian and send him/her a start-up packet which includes the first month's supply of drugs. You will then need to schedule an appointment with your veterinarian to pick up the packet and review the enclosed information. Two weeks after starting the drugs, your pet will have blood and urine samples collected for evaluation of therapeutic drug levels and health monitoring. At the end of each month, you will need to schedule an appointment with your veterinarian. During this visit you will turn in the records you have been asked to keep, receive the next month's packet, and your dog will have blood and urine samples collected for continued monitoring.

Are the drugs that will be used in the study to treat epilepsy safe?

Both drugs selected for this study have been used in dogs without life-threatening side effects being detected. Your dog may experience some side effects from drug therapy which could include: -sedation and grogginess

-increased appetite

-increased water consumption

-increased urination

-hyperactivity

Which drug will my pet receive?

The study in which you are participating is called a "double-blind" study. In order to prevent you and your veterinarian from having a biased interpretation of your pet's response to treatment, neither of you will know the identity of the drug your pet is taking. The investigators at Texas A&M University will know with which drug your pet is being treated, and will make the identity known to you and your veterinarian if necessary. At the conclusion of the study you will be made aware of the drug your pet was treated with. It is important to remember that both drugs are proven anticonvulsants, neither is experimental.

Why will my pet have monthly blood work done?

Lab work will be done monthly for two reasons. The first is to monitor the overall health of your dog. Prior to starting any test medication, your pet will have blood drawn and the results from that blood work will provide the investigators and your veterinarian with a set of baseline, or "normal", values for your dog. Each month during the study, the new lab work results will be compared to the first to detect any possible changes in your pet's health. The second reason for monthly blood work is to monitor the drug levels in your pet's system. The control of seizures is most likely to occur when adequate amounts of drug are present in your pet's system. Therapeutic drug monitoring allows the investigators to make sure that drug levels are at the correct levels, and to change the dose if they are not.

What happens if my pet does not respond to the drug?

It is important for you to understand that it will take several weeks for the drugs to take full effect. If your pet continues to be unresponsive to treatment, a blood sample will be taken to determine therapeutic drug levels. If the drug levels are too low, the dose will be increased. If the blood levels prove to be adequate and your pet still has not responded, then a different approach will be made to control the epilepsy. It is always possible that your pet will not respond to any anticonvulsive drug.

How will I know if my pet is reacting adversely to the drugs?

You should watch for:

-vomiting

-diarrhea

-weakness

-loss of appetite

Your pet may become groggy while the drug dose is "fine tuned". Grogginess is an expected side effect of any anticonvulsant drug and is part of the reason these drugs control seizures. Grogginess usually resolves in 1 to 2 weeks. It is very important that you note any changes, regardless of how small, in your dog's behavior and call your veterinarian or the study investigators if you have questions.

Can I withdraw my pet from the study at anytime?

Yes. Withdrawal from the study will not change the care your dog receives from your veterinarian or Texas A&M University. However, you still be responsible for the $20/month charge for every month your dog was on the study. If you do withdraw, you are strongly encouraged to continue with veterinary care for your pet because uncontrolled seizures can be life threatening. DO NOT DISCONTINUE ANY ANTICONVULSIVE MEDICATION WITHOUT THE APPROVAL OF YOUR VETERINARIAN. Rapidly discontinuing any anti-convulsive drug can lead to uncontrolled seizures.

Will I have to travel to Texas A&M University?

If a diagnosis can be made telephonically, a trip will not be necessary. If a diagnosis can not be made by phone, at least one trip to Texas A&M or another neurology referral center will be required to confirm your pet's eligibility to participate in the study. During this visit a typical work-up for epilepsy may be performed. If your veterinarian has successfully done this, the diagnostics will not be repeated. Other trips to Texas A&M will be made only at your request or if they are recommended by the investigators or your veterinarian. If you wish to travel to Texas A&M, simply have your veterinarian call to schedule an appointment for you with one of the study investigators.

What are my financial obligations to the study?

The Canine Health Foundation and Texas A&M University will pay 50% of the cost for therapeutic drug monitoring and diagnostic testing. In addition, the study will provide all anti-convulsive drugs. You will be expected to pay 50% of the cost of therapeutic drug monitoring. Your approximate cost is $20 per month for 6 months, plus a one time fee of $20 to determine your dog's baseline levels. The total cost to you is approximately $140. The study will pay for the remaining costs of drugs and testing which is approximately $600. The study will not pay for your veterinarian's charges for monthly sample collection. The study also will not pay for costs associated with diagnosis and treatment of illnesses not associated with epilepsy.

What other obligations do I have to the study?

Since the success of the research depends upon the ability to notice changes in seizure activity of the dogs in the study, it is critical that owners keep accurate records noting pet's behavior, health, and seizure episodes. You will be provided with a 30 day log to keep these records on. You will turn this form in to your veterinarian when you bring your pet in for its monthly blood sample collection. Your veterinarian will forward the form to Texas A&M University. Failure to follow the dosing regimen established for your pet is grounds for termination from the study. How long will I participate in the study? The study will run for three years, but your commitment is for only six months. A longer commitment may be necessary if your pet's seizures prove difficult to control.

Will I have any contact with the study investigators?

Communication with the investigators at Texas A&M will occur in many ways. Monthly visits with your veterinarian, in which you turn in your 30 day logs, will serve as important communication. A study technician will call you twice monthly to remind you of rechecks with your veterinarian. The investigators and the study technician are always available to answer any of your questions.

What happens when my part of the study is completed?

Upon completion of the study you will receive a free, one month supply of drug, a certificate for participation, and a 50% discount on all therapeutic drug monitoring done by our lab for the lifetime of the pet who participated in the study. The investigators will continue to be available to make suggestions about your dog's therapy and answer questions from you or your veterinarian. Also, a study technician will continue to call you once every 3 months for two years after you complete the study.


AKC - CANINE HEALTH FOUNDATION

The purpose of the American Kennel Club's Canine Health Foundation is to develop resources for basic and applied health programs that will improve the quality of life for dogs and their owners. One of the ways the AKCCHF works toward the goal of enhancing and lengthening the lives of dogs is funding scientific research. The Canine Health Foundation accepts and welcomes private donations to help support their goals. More information can be obtained by calling (212) 995- 0807 or visiting the Web site at:  http://www.akcchf.org

Should you have a concern regarding the health of your Beagle(s), you should contact your veterinarian. All information on this site is presented solely for educational and informational purposes and should not, at any time, be considered a substitute for seeking or receiving veterinary care for your Beagle(s).