Foundation-Funded RLS Study Hits the Ground Running

In May 2017, John Winkelman, MD, PhD, of Harvard Medical School was awarded a two-year RLS Foundation grant for $144,000 to produce a pilot study on the use of opioids to treat restless legs syndrome. His study, “Multi-center Longitudinal Pilot Observational Study of Efficacy and Tolerability of Long-term Treatment of Restless Legs Syndrome Using Opioids," aims to establish the long-term safety and effectiveness of opioids for managing RLS symptoms, leading to the development of a National RLS Opioid Registry.

In the age of augmentation, opioids have been a successful strategy in treating those with refractory RLS (RLS that is not responsive to other treatments). The work of RLS pioneers Sir Thomas Willis in 1672 and Karl-Axel Ekbom in 1945 supports opioids as a viable treatment option, yet modern clinical studies are limited. The current opioid crisis is also restricting many healthcare providers from prescribing these medications – a lifeline to many who are suffering with severe RLS. Dr. Winkelman's study hopes to bridge the gap in information among the medical community by gathering data on the efficacy and safety of opioids for the treatment of RLS.

"The survey instruments for the [study] were modified and improved based on valuable feedback from RLSF [volunteers], members of the RLSF, and clinicians at the Quality Care Centers," Dr. Winkelman said. "We aim to accurately answer questions about the efficacy and safety of opioid medications for the treatment of RLS, and in doing so, we are keeping with the RLSF’s mission to improve the lives of those living with RLS."

How it will work

Participants in Dr. Winkelman's study will do a phone interview with a researcher for approximately 45 minutes. These questions will prompt responses about RLS symptoms, past and current medications, dosages, and opioid side effects, as well as more sensitive information about psychiatric conditions and other opioid risk factors.

Afterwards, participants will complete an online survey which will cover medical history, sleep behavior, habits, recreational drug use, and mood. Every six months following the initial phone interview, participants will receive a follow-up online survey that will take about 30 minutes, covering a combination of follow-up questions from the phone interview and the online survey.

How to get involved

Enrollment is limited to:

1. Individuals with a diagnosis of RLS (confirmed by the Hening-Hopkins Telephone Interview at the start of the phone interview)
2. Who are taking an opioid medication for RLS (which may be confirmed by state prescription drug monitoring programs)
3. Have taken (or are currently taking) a dopamine agonist for RLS treatment

Dr. Winkelman and his team are recruiting participants from patients of RLS Quality Care Centers and through the RLS Foundation. If you are interested in participating in this groundbreaking study, contact Dr. Winkelman and his research team directly:

• Call: Julia Purks, 617-643-2082
• Email: RLSregistry@partners.org
• Visit: www.massgeneral.org/rls-registry

"I would like to thank the members of the Restless Legs Syndrome Foundation for their generosity and support," Winkelman said. "[This study] is important for the future of RLS treatment, and I am grateful for the opportunity to build it."

John W. Winkelman, MD, PhD, is a Professor of Psychiatry at Harvard Medical School and director of the RLS Quality Care Center at Massachusetts General Hospital. He has served on the RLS Foundation Medical Advisory Board (now the Scientific and Medical Advisory Board ) since 2000, and on the Executive Committee of the International Restless Legs Syndrome Study Group. He was also chair of the Treatment Guideline Committee for the treatment of RLS at American Academy of Neurology.

Dr. Winkelman’s research interests include sleep-related movement disorders, insomnia and parasomnias. He is a leading expert on RLS, has published several textbooks, and has authored over 100 articles in sleep medicine. Notably for RLS, he published seminal work on cardiovascular disease and on end-stage renal disease.