Frequently asked questions |
- What is a clinical trial?
Just like new medications for people, new drugs for animals must be tested for safety and effectiveness. This specific trial is regulated by the FDA (Food and Drug Administration) in order to evaluate a potential new treatment (medication) for dogs with idiopathic epilepsy.
- Are all clinical trials regulated by the FDA (Food and Drug Administration)?
No, and it is always wise to ask before enrolling your pet. The FDA is the government agency that is concerned with the effects of foods, drugs and cosmetics on humans and animals. Before a new animal drug can be approved by the FDA, it must undergo extensive safety and effectiveness testing, just like new drugs for humans. Clinical trials regulated by the FDA must be conducted according to strict protocols that ensure the exact same procedures are used at each study site.
- What are the benefits of volunteering my dog for this trial?
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Free diagnostic tests and evaluation: All tests required by the study protocol, such as blood work, are free. Dogs that are over 5 years of age may also receive a free CT scan or MRI. |
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Free treatment: Your dog will either be given the current FDA-approved treatment for epilepsy or the test medication, either of which may help your dog’s symptoms. |
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Free gifts for you and your dog: All participating dog owners receive gift items in appreciation of your time. |
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Up to $330 in services at your veterinary hospital: If your dog is enrolled in the treatment phase of the study, you may also receive a pre-paid gift certificate for goods and services at your veterinary practice for $110, $220, or $330 (based on the number of treatment periods your dog completes and the time required for your dog to be in the trial) upon completion of your dog’s participation in the study. |
- How do I participate?
Your veterinarian will help you schedule an appointment for a preliminary evaluation of your dog with the clinical investigator (veterinarian) in your area.
- Are there any risks involved to my dog?
As with all medications, there are risks and benefits. The clinical investigator (veterinarian) will cover these with you upon your dog’s preliminary evaluation.
- Are there any costs involved?
No, costs for all tests and medications required for the study are paid by the study sponsor.
- Who is paying for the trial?
A major animal health pharmaceutical company is sponsoring the study.
- Is there any chance my dog would get a placebo?
No, your dog will be given either the FDA-approved treatment for idiopathic epilepsy or the new test medication that is being evaluated in the trial. Your dog will NOT be placed on placebo (pill that contains no medication).
- What is a positive control?
A positive control is a scientific term used to describe a treatment that is known to have a positive effect. Some studies compare a placebo (pill that contains no medication) to the test medication. However, in many studies, not treating a patient would be inhumane, so a positive control is used.
- What will be expected of me if I enroll my dog?
You must be willing to give your dog medication as directed and take your dog in for regularly-scheduled visits to the investigator’s hospital.
- Can I contact the clinical investigator in my area directly without going through my veterinarian?
No, it’s important that your veterinarian refer your dog into the study.
- Where are the appointments?
Your veterinarian will give you the name, address, and phone number of the clinical investigator’s veterinary hospital.
- How many times will I need to take my dog to the investigator’s hospital?
On average, you will need to take your dog to the investigator’s hospital once per month, depending on your dog’s response to treatment.
- Can all dogs with seizures participate?
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Have been diagnosed with idiopathic epilepsy |
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Are at least 4 months old |
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Have no known prior or current treatment with any antiepileptic drug |
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Weigh 11 lbs. or more |
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Have no previous history of seizure clusters or status epilepticus |
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Are not pregnant or suspected to be pregnant |
- How can I learn more?
Ask your veterinarian or call 1-888-598-7125, ext. 208.
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