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 a study drug 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 Clinical Investigator, who will give you information about how to do this safely.

What should I expect?

Before you can take part in the KINECT-HD Study, you will first need to provide consent and attend the screening visit(s) for initial tests and assessments to see if you are eligible to participate. If the completed screening tests and assessments confirm you are eligible to participate, you may be entered into the study. Participants will be randomly assigned – like the flip of a coin – to receive the valbenazine or placebo. For the first eight weeks you will receive increasing doses of the study drug. The placebo looks like valbenazine, 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.

After eight weeks, you will continue to receive the study drug or placebo at the same dose, for four more weeks.