Frequently asked questions

Here, you will find answers to other questions you may have.
Clinical trials are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential medicines and other medical treatments affect the participants. All medicines and vaccines that become available today for use in patients are first tested in clinical trials.

The OPTIMA Clinical Trial is testing an investigational drug as a potential treatment in people with FOP. The drug being tested is called “investigational” because it hasn’t been approved for use outside of this clinical trial. For more information regarding the trial, visit the About OPTIMA section.

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

Approximately 66 people worldwide are expected to participate. To find your nearest clinical trial site, please visit our Site Finder.
If you decide to participate and are eligible, you will be in the trial for about 2 years. During this period, you may leave the trial at any time without consequences to your usual medical care. Your participation is entirely voluntary. If you decide to participate and remain in the trial, your responsibility is to follow the trial guidelines (e.g., attending the trial visits and completing all procedures, informing the trial team about any changes to your health, and completing your electronic diary daily). These guidelines will be explained to you in detail during the screening process.

Participating in any clinical trial involves possible risks. The known and unknown risks of participating in this trial will be explained to you during the informed consent process, which takes place before you decide to participate. These risks include, but are not limited to, unwanted side effects of the investigational drug and/or that the investigational drug may not provide you with any benefit.

Clinical researchers must follow regulatory guidelines and requirements to help protect the rights, safety, and well-being of clinical trial participants. One example of these guidelines is Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.

There are in addition several entities that provide oversight of clinical trials. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.

The main reason this trial is being conducted is to find new treatments for FOP. Because the treatment in this trial is investigational, you may or may not receive any health benefit from taking it (if you are assigned to the group which will receive it). By deciding to participate in the trial, you help us gather important information on the investigational drug, which may help future patients with FOP.
The trial is taking place in multiple countries worldwide. To find a clinical trial site near you, visit our Site Finder

Do you have other questions?

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