FAQs

A clinical research study is a medical research study in people. The potential treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential treatment through clinical studies. A clinical study helps us learn how an investigational treatment works in the body. Clinical studies must be reviewed and approved by a regulatory agency. In the United States, it’s the Food and Drug Administration (FDA). In Canada, it’s Health Canada. In Europe, it’s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.

The first step is discovering and developing an investigational medicine to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like the potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment that is already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better.

For more information regarding the study, visit the About the PINNACLE study section.

To see if you are eligible, take our questionnaire in the Am I eligible? section.

About 81 people with POTS in the United States and Canada are expected to participate in the PINNACLE study. To find your nearest study site, please visit our Site Finder.

You will receive information on what to expect, as well as your role and responsibilities if you join the PINNACLE study. You may leave the study at any time without it affecting your regular health care. If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures. 

Your participation in the PINNACLE study may last up to about 18 weeks.

You will also help us increase our medical understanding of POTS which may benefit others in the future with this condition. 

The Informed Consent Form talks about all known risks. Feel free at any time to let your doctor know if you have any questions, they will be happy to help you.

Clinical studies are 100% voluntary. You can stop at any time. 

If you have additional questions about taking part in this study, you can share this website with your doctor to discuss this clinical research study. Additionally, you can also contact a clinical site near you: Site Finder.