Clinical Trials

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 All studies must be approved by the Institutional Review Board (IRB) to qualify. There is no charge to publish a listing.

Current Clinical Trials

May 2018

Completed Suicide in Restless Legs Syndrome

Restless legs syndrome (RLS) is a condition associated with sleep deprivation, emotional distress and depression, which may further carry the risk of self-harm. Researchers at Yale University’s Department of Neurology, led by Dr. Brian Koo, are conducting a study to better understand the factors associated with completed suicide in RLS. In the study, Dr. Koo and his research team are seeking assistance from family members who have lost loved ones to suicide where RLS was present. They understand that this is a highly sensitive issue and are mindful of the pain that suicide brings to families. The information gained from this study will help researchers and medical providers learn more about the severity of RLS and understand its relationship to suicide risk. By identifying risk factors for suicide in RLS patients, our goal is to institute measures to prevent this from occurring and impacting other families.

Family members will communicate by telephone with Dr. Koo’s research team to complete a series of questionnaires that address the psychosocial and emotional state of their love one due to the burden of disease associated with RLS.

If you are aware of someone who had RLS, and committed suicide, please consider passing on this information to the family.

To get in touch with our team, email Dr. Brian Koo at or phone (203) 932-5711 ext. 5416.

December 2017

New Drug Trial in Houston

Dr. William G. Ondo of Houston Methodist Neurological Institute is recruiting subjects for a drug trial of a new medicine to specifically treat RLS patient who are currently suffering from augmentation while still taking dopamine agonist medications. The study requires 6 or 7 visits (90-120 minutes) in Houston over a 14-week period. All patients will receive the drug for half the study and a placebo for the other half. There is no cost to be in the study nor any payments made to you for participating in the study.

Patients must now require a higher dose of a dopamine agonist – pramipexole (Mirapax), ropinirole (Requip), or rotigotine (Neupro) than what was originally prescribed to control RLS symptoms. Concurrent use of gabapentin, pregabalin (Lyrica) and gabapentin enacarbil (Horizant) is allowed, but RLS symptoms must still be problematic, and they must start earlier in the day than in the past (augmentation). Medicines that are not allowed include any opioid (narcotic), bupropion (Wellbutrin), and Prozac.

If you are interested and think you qualify, please email and provide your name and phone number.

December 2017

Opioid Use to Treat RLS

Dr. John Winkelman is building an RLS Opioid Registry based at Massachusetts General Hospital with patients from across the United States to assess the long-term safety and effectiveness of opioid medications for RLS.

The RLS Opioid Registry will collect information from people who have been diagnosed with RLS and are taking (or planning to take) a prescribed opioid as a treatment for symptom management. The information collected will be used to evaluate specific treatments and outcomes for those living with RLS.

How can you participate?

Call: Julia Purks, (617) 643-2082

Note: We will not be providing any consultation, advice about clinical care, or medication through this study.

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,
Erin Kraus, RN, 513-544-5030,

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,

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,

Full Clinical Trial Details

Further Reading

Clinical Trials

Clinical Trials: What to Know Before You Go

Inside: Important Information for those considering clinical trail participation

Read More