What you should know about clinical research studies.

What is a clinical research study?

Clinical research studies, also called clinical trials, are research studies in which participants are asked to take an investigational medication under the supervision of a physician and other research professionals.

Clinical research studies must be approved by an institutional review board (IRB). An IRB is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with study-required medical tests and exams before, during, and sometimes even after the study.

Can I leave the study if I change my mind?

Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time for any reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.

What should I expect?

Before you can take part in the Kinected 2 Study, you will first need to attend the screening visit(s) for initial tests and assessments to see if you are eligible to participate. If, after all necessary tests and assessments have been completed, you are eligible to participate, you will be entered into the study. For the first eight weeks you will receive the investigational medication. After eight weeks, you may continue to receive the investigational medication or a placebo. (The placebo looks like the investigational medication, but it does not contain any active medicine. Researchers use a placebo to see if the active medicine works better or is safer than not taking anything at all.) Participants will be randomly assigned – like the flip of a coin – to receive the investigational medication or the placebo.

How long will study participation last?

Participation in the study lasts approximately 26 weeks.

Learn more about the Kinected 2 Study. See If You May Qualify