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Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

A placebo is a treatment that looks exactly like the investigational drug but contains no active ingredients. In clinical trials, researchers often compare an investigational drug with a placebo. All of the participants receive the same level of quality care, regardless of whether they are assigned to receive the investigational drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the drug.

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

All personal information collected for this study will be securely stored in the study medical records at the clinical study site. Sponsor staff, review boards, ethics committees (that approve and monitor studies), and others who have a need to know, such as our data hosting provider and government regulators, may check study records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify study procedures and/or data. If you share your personal data with a clinical study site, that data will be used by Citeline Connect to contact you about clinical studies and related information.

The study team respects and protects your privacy and will not share your information except as required by law. They will store your personal information with codes that do not identify you.

You will not be paid for taking part in the trial. If you are eligible, the study team can tell you about reimbursement for costs you have while being in the trial.