Clinical Trials

While the RLS Foundation does not conduct clinical trials, we do list clinical trial opportunities below and in our quarterly member newsletter, NightWalkers. If you are interested in participating in a study, please scroll down to contact the researcher listed below. Clinical trials are research studies that enlist volunteers to investigate specific health questions. When carefully conducted, they are the fastest and safest way to find treatments that actually work for people. When you volunteer for a restless legs syndrome (RLS) clinical trial, you explore emerging treatment options for yourself while actively contributing to the advancement of RLS research. If you are a researcher who would like to include your study in our listings, please contact us at info@rls.org. All studies must be approved by the Institutional Review Board (IRB) to qualify. There is no charge to publish a listing.

July 2017

A Clinical Trial of BioFe, Medical Food for the Dietary Management of Iron Deficiency

This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.

BioFe, Medical Food for Iron Deficiency is nutritional/Baker's yeast (Saccharomyces cerevisiae), expressing the Ferritin protein. Ferritin is an indispensable iron storage, transport and absorption protein normally produced at low levels by almost all living organisms. An illustrative example of the biology of the Ferritin/Iron complex is its presence in human breast milk, providing infants the natural biological iron required for rapid learning and development, without gastrointestinal upset. BioFe provides high level expression of Ferritin that is naturally complexed with iron during culture, is pasteurized, and dried.

Contact: Darren Wolfe, PhD, 412-352-2498, DWolfe@SideroBio.com
Erin Kraus, RN, 513-544-5030, ekraus@siderobio.com

Full Clinical Trial Details

May 2017

The Emotional State in RLS

RLS is associated with emotional distress and depression. Researchers at Yale are conducting a study that looks at this emotional stress and depression. The study is entirely an on-line questionnaire study. You will not need to talk to anyone to complete this study and it is completely anonymous. There is no way for the researchers or anyone to determine your identity even after you have completed the questionnaires. The first set of questions are to determine if you are eligible. We are looking to study primary RLS, that is RLS that occurs in the absence of diseases like, Parkinson disease, multiple sclerosis, severe neuropathy, end stage renal disease, schizophrenia, terminal cancer, and others. The questionnaires will take about 20 minutes to complete.

We also need a control group, so we ask that you identify someone without RLS that also does not have conditions, such as the ones mentioned above. For controls filling out the questionnaires will take under 10 minutes.

Yale University Department of Neurology

Contact: Dr. Brian Koo, (203) 932-5711 x 5416, brian.koo@yale.edu

Full Clinical Trial Details

May 2016

Investigational use of intravenous (IV) iron with ferric carboxymaltose (Injectafer) for the treatment of RLS. Injectafer is approved for use by the U.S. Food and Drug Administration (FDA) to treat adult patients with iron deficiency anemia (IDA) but it is not approved to treat RLS symptoms.

John W. Winkelman, MD, PhD, with the Sleep Disorders Clinical Research Program, Massachusetts General Hospital

Contact: Leslie Mei, (617) 643-6026, lamei@partners.org

Full Clinical Trial Details

March 2016

Does your child have discomfort in their legs that may interfere with their sleep? Worldwide Clinical Trials is conducting research studies to test an investigational medication for the treatment of adolescent RLS.

Worldwide Clinical Trial

Contact: Camilla Alexander, (520) 252-1908, Camilla.Alexander@wwctrials.com

Full Clinical Trial Details

January 2013

Determining whether there are changes in the retinal structure of the eyes of individuals with RLS compared to individuals with Parkinson’s disease, multiple system atrophy, and healthy controls.

New York University Langone Medical Center

Contact: Dr. Jose Martinez, Jose.Martinez@nyumc.org

Full Clinical Trial Details