Restless Legs Syndrome: You’re Ready to Rest, But Your Legs Aren’t.

A Patient’s Guide to Participating in Restless Legs Syndrome Research

Every day, research uncovers new information about diseases and their treatment. By taking part in a clinical research study, you are an important link in a long chain of research and testing of new investigational medicines for future use.

What is a clinical study?

A clinical research study is also called a clinical trial. Each study tests the safety, effectiveness, and side effects of an investigational medicine(s) or an investigational device on a group of volunteers. Clinical research studies are an important step in making new investigational medications available for future use.

An ethics committee must review clinical research studies before they begin. In addition, the FDA (Food and Drug Administration), a department of the US government, sets requirements for drug testing. They also review the results from certain clinical research studies to decide if an investigational drug should be made available to the general public.

Who can be in a clinical research study?

Each clinical research study has different requirements for participants, such as age, sex, or medical condition. It is important that different kinds of people are involved in the trial, including men and women from different races. People respond differently to medicines and other treatments so it is important to include all kinds of people.

The research team will look at your medical history and study requirements to find out if you are eligible. The team will also tell you what it means to be involved in the study and what the risks and benefits are during the informed consent process.

What can I expect as a study volunteer?

During the study, the team will review your medical history, give you instructions for participating, and monitor your health. Some clinical research studies may involve more tests and doctor visits than you would normally have for an illness or condition. Study-related physical examinations, laboratory tests, and study medications are usually provided at no cost throughout the study.

What is restless legs syndrome (RLS)?

Restless Legs Syndrome (RLS) is a movement disorder characterized by an urge to move the legs, usually accompanied by uncomfortable sensations in the legs that only occur or are worse during periods of rest or while sitting or lying down, particularly in the evening or at night. Moving the legs brings at least temporary relief. Individuals affected with the disorder may describe the sensations with words like pulling, creepy-crawly, wormy, burning, throbbing, and painful.

Who qualifies for restless legs syndrome (RLS) studies?

This study involves an investigational use of a marketed drug.  You may qualify for this study if you meet the following basic criteria:

• Male or female

• 18 to 79 years of age

• Experiencing RLS symptoms