Current Clinical Trials

Posted September 2022

Open Label Trial of Pitolisant as Adjunct Therapy for RLS

Dr. William Ondo, director of the RLS Foundation Quality Care Center at Houston Methodist Hospital, is recruiting patients who are taking RLS medicines but do not have satisfactory response. Participants will add a medicine called pitolisant, which is a histamine-3 inverse agonist and is currently used to treat narcolepsy. Patients will take this medicine while they stay on their current RLS medications for the first two months, but can make any changes deemed necessary to their other medications over the next two months. The study will require four visits to Houston Methodist, and several phone calls after establishing care in the clinic. In this study everyone will receive the active medicine. To qualify, participants must be 21 years or older.

Contact: Shivani Desai, BS, (713) 363-8390

Updated July 2022

Do you continue to have insomnia even though your RLS is well controlled? Update: Now enrolling patients treating their RLS with opioids.

Many people continue to experience insomnia even though their RLS is under good control. Such sleeplessness is often distressing and can produce negative daytime consequences. John W. Winkelman, MD, PhD, with the Sleep Disorders Clinical Research Program, Massachusetts General Hospital (MGH), is conducting a research study, performed virtually by video and/or phone, investigating the efficacy of an FDA-approved sleep medication (suvorexant, Belsomra) for the treatment of such people.

This is a double-blind placebo-controlled crossover study of 10 weeks duration. Participants will not change their RLS medication during the study. Inclusion in the study will be based on a 4-week screening period in which participants keep sleep diaries and 2-week period in which they wear an activity wristband. Accepted participants will receive a 4-week supply of either suvorexant or placebo followed by a 4-week period in which they receive a 4-week supply of the other study medication (either suvorexant or placebo). Neither you nor the study doctor will know which shipment (the first 4-week period or the second 4-week period) is the active drug.

Participants will attend 6 virtual meetings over video conference and 2 brief phone visits with Dr. Winkelman. The study will take approximately 10 weeks to complete. Participants will be compensated up to $250 for completion of the study. To qualify, participants must be:

  • Over 18 years old
  • Experiencing RLS that is well-controlled by medication
  • Living in New England or California

Participation in this study is entirely voluntary and would not change the RLS care that you receive. All of the information that we learn from the study will be kept confidential. Your name and other personal information would not be attached to the study data.

Contact: For more information, please contact research coordinator Jordana Zackon at 617-643-6026 or Please also share this information with family members or friends who may be interested.

Posted December 2019

Hormones and Their Role in Restless Legs Syndrome

We need YOUR HELP RLS Community!! We have received funding from the Department of Defense to continue our study of hormones in RLS. This means that we are able to reimburse you for the COST OF YOUR TRAVEL (up to $600) as our research requires a one-time visit to New Haven, Connecticut. Our research aims to uncover the underlying biological mechanisms of RLS. Doing this is essential in order to develop new more effective treatments for RLS and to discover a cure.

Brian Koo, MD and his team at Yale University are conducting research to determine whether levels of specific hormones are increased in the blood and spinal fluid of persons with RLS. The research requires that participants undergo blood draws and a spinal tap.

We are looking for individuals with moderate to severe primary idiopathic RLS who do not have other disorders such as kidney disease, multiple sclerosis, Parkinson disease, or severe neuropathy AND who are not currently taking medicine for RLS. If you are taking medicine for RLS, you can discuss with Dr. Koo about temporarily coming off of your medicine. We know that coming off your medicine, even temporarily, and undergoing a spinal tap are a lot to ask, but this research is important and we need YOUR HELP!!

If you believe you are eligible or have any questions about the research, please contact our study team led by Dr. Brian Koo, MD.

Contact: Your first contact can be via email to Brian Koo, MD at or call (203) 785-4261

Posted October 2018

RLS & My Teen: What’s Next? — Fight RLS with Science

Is it really tough to get to sleep sometimes? Find out about a study that’s for adolescents dealing with RLS. Sometimes, RLS is often misdiagnosed with a with range of issues, including growing pains or behavioral problems—and that can be tough on everyone around them. Now your child can participate in a study for 13–17-year-olds with RLS. Compensation available. This study is open to those with RLS and living in CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WI, WV.

Call: (310) 464-2190

Posted January 2013

If you live in the New York City area, you may be eligible to participate in a new research opportunity.

We are conducting a research study to determine whether there are changes in the retinal structure of the eyes of individuals with Restless Legs Syndrome, also known as Willis-Ekbom Disease (WED/RLS) compared to individuals with Parkinson’s disease, multiple system atrophy, and healthy controls.

The study will take place at the New York University Langone Medical Center and will require one visit, lasting approximately 1-2 hours. The visit will include an initial screening and an eye exam. You will be asked to sit comfortably and to place your chin in a chin rest and to look into a machine that will take pictures of your optic nerve. The eye examination will take approximately 15 minutes and you will not feel anything while the machine takes pictures of your retina (the back of your eye).

There is no direct benefit to you or expense reimbursement available from your participation in the study. It is hoped that the knowledge gained will be of benefit to others in the future. Studies done for this research study are not a part of your regular medical care and will not be included in your medical record.

If interested, please contact Dr. Jose Martinez at

Further Reading

Clinical Trails: What to Know Before You Go

Inside: Important Information for those considering clinical trail participation

Read More