Medical breakthroughs come from research into all kinds of diseases and illnesses, including restless legs syndrome (RLS). Different types of research include laboratory studies, clinical trials with patients, genetic studies, and much more.
Scientists may focus their research on how to treat or prevent RLS, its effects on the emotions or social life, and more. Research may take years before it changes how RLS is treated, but new research goes on all the time. Gradually, the treatment of RLS improves thanks to research and the volunteers who join clinical trials.
Clinical trials for restless legs syndrome
Clinical trials are an important part of medical research. A clinical trial tests new drugs, surgeries, or devices that help prevent, diagnose, or treat a disease. You can volunteer for a clinical trial if you meet certain conditions. These conditions vary with each clinical trial but may include age, willingness to use a new drug or device, ability to go to regular doctor appointments, or presence of other health conditions. You will be carefully followed during the trial, and you can stop your participation at any time.
The U.S. Food and Drug Administration (FDA) approves and oversees all clinical trials conducted in the U.S. In addition, hospitals tied to universities manage clinical trials through institutional review boards (IRBs). IRBs review the way a study is designed and any supporting research to protect patients. For a doctor or company to hold a clinical trial, it must be approved by one or both of these groups.
Often, any medical care related to the trial is provided to the patient at no cost because it is experimental.
Dozens of clinical trials are underway to improve our understanding of restless legs syndrome and its treatment. Some areas of current research include:1-2
- The link between sensory and motor systems in people with RLS
- Use of botulinum toxin (Botox™) to treat RLS
- Use of a foot massager and heat to treat RLS
- RLS in people with Alzheimer’s and on dialysis
- Comparison of yoga versus RLS education to see which is most effective
- New drugs and existing drugs to treat RLS
Phases of clinical trials
Clinical trials come in 4 stages. Each stage, or phase, is designed to test the safety and usefulness of the new drug, device, or treatment protocol. Here are the general stages of a clinical trial:3
- The pretrial phase is conducted on animals other than humans. This is done to decide if the drug or device is safe enough to test in humans.
- Phase 1 lasts 1 month, and includes roughly 20 to 80 people.
- Phase 2 lasts 3-12 months and includes a few hundred people.
- Phase 3 lasts 6-12 months and includes thousands of people.
- If found safe, the drug or device company files for FDA approval. Approval usually takes 6-12 months.
- Phase 4 begins after a drug has been released onto the market. The agency watches for serious and long-term side effects that were not found during early testing.
A clinical trial may be shut down at any stage if the doctors find that the new treatment harms people or has no effect.
Where to learn more about RLS research
If you are interested in learning more about clinical trials, ask your doctor if one might be right for you. You can also learn more about restless legs research through several websites, including:
Talk to your doctor about what you find online since sometimes it is not always easy to understand all the medical jargon. Your doctor may also be able to explain why you may or may not be a good fit for a study and whether there is other research that applies to you better.