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Clinical Trial 15977

San Angelo, TX 76904

Study Summary:

Does Restless Legs Syndrome have you going in circles?

If you have been diagnosed with moderate to severe Restless Legs Syndrome (RLS) or believe you are experiencing RLS symptoms, the CONCORD clinical research study may be right for you.

Why is the CONCORD study taking place?

The drug being evaluated in the CONCORD study has been approved by the U.S. Food and Drug Administration (FDA) at a specific dose strength for the treatment of RLS.

The CONCORD study is being done to learn more about the drug when it is given in two investigational lower dose strengths, as well as the approved dose strength, when compared with placebo. A placebo looks like the approved RLS medication but contains no active ingredients.

The two lower dose strengths of the medication are considered investigational in this study because they are not yet approved by the FDA for the treatment of RLS.

Who can participate in the CONCORD study?

You may be eligible for further screening for the CONCORD study if you are:

  • At least 18 years of age
  • Experiencing RLS symptoms for at least 15 nights in the month before beginning the study or, if currently receiving RLS treatment, 15 nights in the month before beginning treatment

All study-related visits, tests, and study drug will be provided to participants at no cost. In addition, reimbursement for time and travel may be provided

What will happen during the study?

If you are eligible and agree to participate in the CONCORD study, you will be randomly placed into one of four dosing groups. Three groups will be given a different dose strength of the study drug, and one group will receive a placebo.

You and your doctor will not know your study drug group assignment. However, in the event of an emergency, this information will be provided to your doctor.

After you have received your group assignment, you will take three tablets of study drug once a day for 12 weeks. You will be instructed to take all of your study drug around 5 p.m. with food.

You will visit the study clinic nine times over approximately 14 weeks, which includes a final follow-up visit one week after you stop taking the study drug. During your visits to the clinic, you will receive your study drug, and the study doctor will monitor your health through various tests and assessments including:

  • Physical examinations
  • Electrocardiograms, which measure the electrical activity of your heart
  • Vital signs measurements (including heart rate and blood pressure)
  • RLS symptom assessments
  • Reviews of current and prior medications
  • Reviews of side effects

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.