LET'S SHINE SOME LIGHT ON A FEW OF YOUR LIKELY QUESTIONS.

 

 

 

Please find answers below to some of the most frequently asked questions. If you should have additional questions, you can contact us directly.

LET'S SHINE SOME LIGHT ON A FEW OF YOUR LIKELY QUESTIONS.

Please find answers below to some of the most frequently asked questions. If you should have additional questions, you can contact us directly.

1. What is a clinical study?

As with new medications for people, new animal drugs must also be thoroughly evaluated in clinical studies such as this one.    

2. What is the purpose of this study?

This is a pivotal clinical study in which the safety and effectiveness of a potential new treatment for thunderstorm aversion will be evaluated, and the data submitted to regulatory authorities worldwide, such as the U.S. Food & Drug Administration (FDA), Australian Pesticides and Veterinary Medicines Authority (APVMA), and European Medicines Agency (EMA), with the goal of achieving the medication’s approval to treat dogs with this condition.

3. What are the benefits of participating in this study to me and my dog?

Everything required for the study is free to owners, and depending on your level of participation, you may receive up to $300 in credits at your primary veterinarian’s clinic at the completion of your dog’s participation. You will be making a significant contribution to veterinary medicine by helping study investigators better understand thunderstorm aversion in dogs. While it is possible that enrolling in this study may have no direct benefits to you or your dog, owners often find participating to be very rewarding. You may also help to bring a new medication to the market which will help dogs in the future.

4. How are the credits paid to my primary veterinarian’s clinic when my dog completes the study?
Your primary care veterinarian’s office will need to complete and send two forms to us: the Acknowledgment form and a W-9 tax form.

Links to the two forms can be found here:
Acknowledgement Form
W-9 Tax Form

We are happy to answer any questions your veterinarian’s office may have. Our contact information can be found here.

5. How many times will I need to visit the veterinary investigator site?

There may be up to four visits in total needed, but only two will require that you bring your dog—the one at the study start, and the one at the study end. During the study, one or two visits without your dog may be needed to pick up medication, depending on how your dog responds to the treatment. You will also have up to two phone calls with the investigator site during the study.

6. How do I get started?

The first step is to confirm if there’s a veterinary investigator site near you.  If you believe your dog also meets the eligibility criteria here, complete this questionnaire, and you will be put in touch with the investigator site in your area.

7. Are there any risks involved to my dog?

As with all medications, there are risks and benefits, all of which will be discussed with you prior to enrolling your dog. 

8. Is there a possibility my dog will receive a placebo?

Yes, 50% of the dogs in the study will receive a placebo (a pill with no medication in it).  The study is masked and even the veterinary investigator team members do not know which dogs receive the test medication or the placebo.  This double-blind, placebo-controlled approach is considered the gold standard for clinical studies, helping to ensure that improvements in patient outcomes are valid, conclusive, and not influenced by anyone involved.

9. Are there any costs involved?

No, everything required by the study for enrolled dogs is free to dog owners, including all diagnostics, exams, and medication. Also, there’s no cost for dogs to be screened to determine whether they qualify for enrollment.

10. Who is paying for the study?

An animal health pharmaceutical company is sponsoring the study.

11. How long does the study last?

Individual study participation may last up to 84 days, or approximately 3 months.

12. What if I enroll my dog and then decide I no longer wish to participate?

If your dog is enrolled, you may opt out at any time, but we hope you will allow your dog to participate until study completion (approximately 90 days). By keeping your dog on study until completion, your valuable data can be presented to FDA and have the greatest potential to benefit dogs in the future.

1. What is a clinical study?

As with new medications for people, new animal drugs must also be thoroughly evaluated in clinical studies such as this one.    

2. What is the purpose of this study?

This is a pivotal clinical study in which the safety and effectiveness of a potential new treatment for thunderstorm aversion will be evaluated, and the data submitted to regulatory authorities worldwide, such as the U.S. Food & Drug Administration (FDA), Australian Pesticides and Veterinary Medicines Authority (APVMA), and European Medicines Agency (EMA), with the goal of achieving the medication’s approval to treat dogs with this condition.

3. What are the benefits of participating in this study to me and my dog?

Everything required for the study is free to owners, and depending on your level of participation, you may receive up to $300 in credits at your primary veterinarian’s clinic at the completion of your dog’s participation. You will be making a significant contribution to veterinary medicine by helping study investigators better understand thunderstorm aversion in dogs. While it is possible that enroling in this study may have no direct benefits to you or your dog, owners often find participating to be very rewarding. You may also help to bring a new medication to the market which will help dogs in the future.

4. How are the credits paid to my primary veterinarian’s clinic when my dog completes the study?
Your primary care veterinarian’s office will need to complete and send two forms to us: the Acknowledgment form and a W-9 tax form.

Links to the two forms can be found here:
Acknowledgement Form
W-9 Tax Form

We are happy to answer any questions your veterinarian’s office may have. Our contact information can be found here.

5. How many times will I need to visit the veterinary investigator site?

There may be up to four visits in total needed, but only two will require that you bring your dog—the one at the study start, and the one at the study end. During the study, one or two visits without your dog may be needed to pick up medication, depending on how your dog responds to the treatment. You will also have up to two phone calls with the investigator site during the study.

6. How do I get started?

The first step is to confirm if there’s a veterinary investigator site near you.  If you believe your dog also meets the eligibility criteria here, complete this questionnaire, and you will be put in touch with the investigator site in your area.

7. Are there any risks involved to my dog?

As with all medications, there are risks and benefits, all of which will be discussed with you prior to enrolling your dog. 

8. Is there a possibility my dog will receive a placebo?

Yes, 50% of the dogs in the study will receive a placebo (a pill with no medication in it).  The study is masked and even the veterinary investigator team members do not know which dogs receive the test medication or the placebo.  This double-blind, placebo-controlled approach is considered the gold standard for clinical studies, helping to ensure that improvements in patient outcomes are valid, conclusive, and not influenced by anyone involved.

9. Are there any costs involved?

No, everything required by the study for enrolled dogs is free to dog owners, including all diagnostics, exams, and medication. Also, there’s no cost for dogs to be screened to determine whether they qualify for enrollment.

10. Who is paying for the study?

An animal health pharmaceutical company is sponsoring the study.

11. How long does the study last?

Individual study participation may last up to 84 days, or approximately 3 months.

12. What if I enroll my dog and then decide I no longer wish to participate?

If your dog is enrolled, you may opt out at any time, but we hope you will allow your dog to participate until study completion (approximately 90 days). By keeping your dog on study until completion, your valuable data can be presented to FDA and have the greatest potential to benefit dogs in the future.