Restless Legs Syndrome Foundation Blog

February 1, 2019

By Kris Schanilec

The RLS Foundation has awarded a $22,100 grant to John Winkelman, MD, PhD, of Harvard Medical School and Massachusetts General Hospital to continue his study on the long-term use of opioids to treat RLS. Dr. Winkelman received a grant from the Foundation in 2017 to support the first stage of this research.

“The funding extension will help the researchers obtain valuable information from long-term follow-up of patients,” says Karla Dzienkowski, executive director of the Foundation. “This is the first study in which patients with RLS who use opioids are monitored over time to evaluate the effectiveness and tolerability of this treatment long-term, and by far the largest observational study of such patients.”

Opioids are an established, highly effective treatment option for people with severe RLS when other therapies have failed. However, concrete data is lacking on long-term use of these medications for RLS. By gathering data over time, Dr. Winkelman’s team will evaluate the effectiveness, tolerability and safety of opioids for treating RLS, and aim to further understand how factors such as behavior and mood may influence opioid effectiveness and safety.

This much-needed data will help physicians and patients make more informed treatment decisions, especially in the face of increasingly strict opioid regulations limiting access at the state and federal levels.

Over the past year, Dr. Winkelman’s team has created a national registry of patients who take opioid medications for RLS. As of December, the researchers had enrolled 360 participants – far surpassing their goal of 200. Participants complete a phone interview and an online survey covering a range of topics related to their RLS symptoms, treatment, medical history, habits and behaviors. They then complete follow-up surveys every six months. All stored information is confidential and anonymous.

The study will remain open to new participants until approximately late June. Enrollment is limited to individuals who have a diagnosis of RLS, are taking an opioid medication to treat their RLS symptoms, and have previously taken or are currently taking a dopamine agonist for RLS treatment. For information about participating, see rls.org.

Please note that no consultation, advice about clinical care, or medication is provided through this study.

SEPTEMBER 4, 2018

Appropriate Use of Opioids to Treat RLS

About 1 in 33 Americans – 3 percent of the US population – have RLS that is severe enough that they need treatment with medications. Unfortunately, treatment options are limited and do not provide life-long coverage. Dopamine agonist medications (pramipexole, ropinirole and rotigotine patch) can actually make the disease worse over time – an effect called augmentation. Alpha-2-delta agents (gabapentin, pregabalin and gabapentin enacarbil) are effective for only 70 percent of RLS patients and can have serious side effects such as suicidal thoughts.

Opioids are an established, highly effective treatment option for people with severe RLS when other therapies have failed. These medications bring dramatic relief to an estimated 90–95 percent of RLS patients. Clinical experience among experts has not shown the degree of drug misuse, dependency or addiction that is commonly associated with opioid use to treat chronic pain, which has a different underlying biology from RLS.

Clinical guidelines published in Mayo Clinic Proceedings are available for clinicians to appropriately prescribe opioids for RLS, assess patients for risk of addiction, and monitor use over time. The RLS Foundation actively conducts educational outreach to help ensure that healthcare providers know how to diagnose and treat RLS, including treatment with opioid therapy.

Learn More About RLS Treatment Options

If you are struggling to control your RLS symptoms, consult with your healthcare provider about which treatment options may be right for you. A good resource to share with your provider is the RLS Medical Bulletin, available in the Member Portal at www.rls.org.

If you are looking for an RLS healthcare provider, visit www.rls.org or contact the RLS Foundation at info@rls.org for information about RLS Quality Care Centers and other providers knowledgeable about RLS.

JULY 15, 2018

In June, the RLS Foundation visited Washington for a second round of meetings to advocate for research funding and for continued patient access to opioid medications to treat severe RLS.

Led by Executive Director Karla Dzienkowski, the Foundation team met with members of Congress who are on key legislative committees that have jurisdiction over health policy, and with two groups at the National Institutes of Health (NIH).

“Our meetings at Congress and the NIH were very important to moving our advocacy program forward,” Dzienkowski says. “We had the opportunity to meet with Congressional staff who are directly involved in opioid-related legislation. We are also excited to be deepening our relationships at the NIH and taking meaningful steps to advance RLS research.”

The Foundation team met with staff in the offices of Sen. Sheldon Whitehouse, D (RI); Sen. Bob Casey, D (PA); Sen. Elizabeth Warren, D (MA); Rep. Markwayne Mullin, R (OK); Rep. Conor Lamb, D (PA); Rep. Katherine Clark, D (MA); and Rep. Michael Burgess, R (TX).

The discussions centered on the need for a safe harbor for RLS in any upcoming legislation or policy that might restrict access to opioid medications. “Staffers shared that over 50 opioid bills are under consideration,” says Dzienkowski. For the millions of Americans who have chronic, unrelenting RLS, opioid medications taken in low total daily doses can be very effective for controlling symptoms.

The Foundation team also asked legislators to support two research priorities: $2 billion in increased funding for the NIH in fiscal year 2019; and continued inclusion of “sleep disorders” as a category eligible for grants by the Department of Defense.

At the NIH, John Winkelman, MD, PhD, gave a presentation on behalf of the Foundation to the Sleep Disorders Research Advisory Board (SDRAB) of the National Heart, Lung, and Blood Institute. Dr. Winkelman is director of the RLS Quality Care Center at Massachusetts General Hospital and a member of the Foundation’s Scientific and Medical Advisory Board.

The SDRAB is a federal advisory committee that sets the strategy for sleep disorders research at the NIH, and the meeting was an opportunity to highlight the unmet needs of RLS patients. RLS Foundation Board member Linda Secretan is one of two patient advocates on the SDRAB.

In his presentation, Dr. Winkelman discussed limitations of RLS treatments and the importance of research, including his current study to evaluate the long-term use of opioids to treat RLS.

“We had a very positive discussion,” Dr. Winkelman says. “It was important to describe the existing landscape of RLS treatment options, particularly as not everyone at the table was fully aware that many people with RLS continue to suffer for a variety of reasons, such as augmentation. It was equally important to raise awareness about the effectiveness of low total daily doses of opioid medications as a therapy for severe RLS.”

The Foundation also visited the National Institute on Drug Abuse and met with members of the Division of Neuroscience and Behavior, which supports research on drug use and addiction. Dr. Winkelman led a lively discussion on the neuroscience of RLS and how new drug therapies might be developed to treat the disease.

“We’re always looking for new ways to intervene to prevent or treat RLS,” Dr. Winkelman says. “We discussed what we already know about what causes RLS in the brain, and the various ways we might learn more about the neurological pathways involved. We came away with new ideas to explore for research.”

The meetings were coordinated by the Health and Medicine Counsel of Washington (HMCW), a government relations organization with nonprofit and healthcare industry expertise that is partnering with the RLS Foundation to guide its advocacy efforts. In addition to Dzienkowski and Dr. Winkelman, the delegation included Kris Schanilec, RLS Foundation communications; and Dane Christiansen, Dale Dirks and Peter Herzog of HMCW.

How You Can Take Action

The RLS Foundation is working hard to advocate on behalf of the RLS community. The Foundation needs you, an RLS patient or family member, to amplify these efforts by meeting with your legislators. You can meet with your members of Congress at offices in your home state or in Washington. Elected officials want to hear directly from their constituents, and sharing your personal experiences is the best way to educate them about the needs of RLS patients.

The Foundation has resources to help you get started. Contact Peter Herzog at herzog@hmcw.org or visit www.rls.org to learn more.

RLS Advocacy: Our Progress

Since October 2017, the RLS Foundation and its partners at HMCW have:

• Delivered letters to members of Congress from 200+ individuals who responded to a request for personal stories about opioid medications and RLS. 
• Attended Congressional meetings and hand-delivered position letters to committees that are crafting legislation related to opioid medications and/or biomedical research funding. These efforts helped support passage of the FY2018 appropriations bill, securing a $3 billion increase in funding to the NIH. 
• Delivered 40 letters to members of the Senate Defense Appropriations Subcommittee from RLS Foundation members who responded to an Action Alert to support inclusion of “sleep disorders” on the Department of Defense Peer Reviewed Medical Research Program in FY2019. 
• Met with 23 Congressional offices, three NIH institutes, the NIH Sleep Disorders Research Advisory Board, and the U.S. Food and Drug Administration (FDA). 
• Coordinated or supported meetings by the RLS Foundation team and Foundation members with US senators and representatives of 13 states.

Why Are Opioids Needed for RLS?

About 1 in 33 Americans – 3 percent of the US population – has RLS that is severe enough to need daily medical treatment. Unfortunately, treatment options are limited, and FDA-approved medications for RLS often have serious, long-term side effects.

When all other options have failed, opioids at low total daily doses are an established, highly effective treatment option for people with RLS. Clinical experience among experts has not shown the degree of drug misuse, dependency or addiction commonly associated with opioid use to treat chronic pain. The RLS Foundation actively conducts educational outreach to help ensure that healthcare providers know how to diagnose and treat RLS, including appropriate use of opioid medications. For more information, visit www.rls.org.

JULY 15, 2018

Contact the Food and Drug Administration (FDA) and ask them to maintain access to opioids in low total daily doses for patients with refractory RLS

Decision makers at the FDA are requesting comments by September 10, 2018 from patients who utilize opioid therapies to manage their chronic conditions. Agency officials want to hear from refractory RLS patients on how they manage their condition and barriers that are affecting their access to treatment.

Background

On Monday, July 9th, the Restless Legs Syndrome (RLS) Foundation participated in a Patient Focused Drug Development (PFDD) meeting hosted by the FDA. The goal of this meeting was to incorporate patients’ voices as the agency develops guidance on opioid therapies for chronic pain, refractory RLS, and other conditions that utilize these treatments.

RLS is not considered to be a chronic pain condition, because its underlying mechanisms and neuropathology are very different. The Foundation urged regulators to appreciate the differences. This is why it’s important for the RLS community to take part in these discussions, because the perspectives shared will inform the FDA’s decision making on regulations that will affect refractory RLS patients who utilize low total daily doses of opioids to manage their condition.

At the July meeting the FDA welcomed input from a variety of people using opioids to manage chronic conditions. The FDA is now seeking input from patients who were unable to attend in person. Written comments will add weight and depth to the presentations made at the meeting.

Given the high level of concern about opioid related deaths, it is critical that RLS patients make their voices heard at this crucial moment in the policymaking process! In response to these questions, always make sure to note that RLS is different from chronic pain and requires any regulations or legislation take this difference into account. Now is your chance to speak up, to share your experiences and frustrations.

Take Action

• Go to the FDA’s online portal for submitting electronic comments to submit feedback at https://www.regulations.gov/document?D=FDA-2018-N-1621-0001 and click on “Comment Now” at the right of the page. 

• Tell the FDA about RLS, how you manage your symptoms, and what kind of barriers have affected your access to treatment. You can use the suggested discussion topics below to inform your comments.

Feel free to answer the questions directly or simply review them to help guide your response:

Topic 1: Symptoms and Daily Impacts

1. How would you describe your RLS symptoms? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)
2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)
3. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
4. How has your condition changed over time? (Considerations include severity and frequency of symptoms and the effects of RLS on your daily activities.)

Topic 2: Patients' Perspectives on Current Approaches to Treatment

1. What are you currently doing to help treat your RLS? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)
a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)
b. What factors do you take into account when making decisions about selecting a course of treatment?
2. How well does your current treatment regimen manage your chronic condition?
3. What are the most significant downsides to your current treatments, and how do they affect your daily life?
4. What challenges or barriers to accessing or using medical treatments have you or do you encounter?

Electronic comments must be submitted on or before September 10, 2018. Make sure to let the RLS Foundation know you participated in this campaign!

Take Action This Summer!

During the summer, elected officials in Washington break for recess and return to their home states. This is an excellent time to meet with and educate them about RLS, how opioid restrictions are affecting access to necessary treatment, and why more RLS research is needed to find a cure.
The Foundation needs you, a valued and essential member of the RLS community, to join in this important work. Your representatives need to hear your personal story about the struggles of living with RLS. These personal anecdotes put a face to the disease and are crucial to share so that legislators are fully aware of the needs of the RLS community when making legislative decisions.
Not sure where to start? It's easier than you think. The RLS Foundation’s advocacy partners at the Health and Medicine Counsel of Washington (HMCW) are available to assist you in planning and implementing these meetings with your representatives. Contact Peter Herzog at herzog@hmcw.org, or keep reading for information on how to get started.

First Steps

Find out who your representatives are. Each US citizen has three representatives in Congress: Two in the Senate, and one in the House of Representatives. You can find out who they are at www.senate.gov and www.house.gov. Just enter your zip code into the search bar in the top right-hand corner of the page to bring up their names. Many of these officials have offices both in Washington and locally, so select the office closest to you.
Reach out to HMCW. Contact Peter Herzog at herzog@hmcw.org, and he will provide you with talking points, a prep packet and other information to help with the meetings. He may also be able to help schedule meetings.
Make an appointment. Call the office of each representative and request an appointment to discuss issues that you and others with RLS are facing. You will likely be given an appointment with a staff member. Keep in mind that you will be meeting as an individual in the community and not as a representative of the RLS Foundation. If you are a Foundation member, please share this during your meeting.
Strength in numbers. You are not alone! Get a group of friends, family members or other RLS patients to go with you to the meeting. You can also find others who have RLS via the Foundation's Discussion Board, support groups and social media channels.

Resources

While you may have many items that you wish to discuss with your representatives, focusing these particular meetings on issues related to RLS will help make the most impact. The goal is to educate your representatives about RLS, how opioid-related legislation affects you and the RLS community, and why more research funding is needed. The Foundation has a variety of resources to help you accomplish this.
Webinar recordings. The Foundation and HMCW have presented two RLS advocacy webinars, available for free viewing in the "Get Involved" section at www.rls.org. These webinars contain excellent introductory information to RLS advocacy efforts and provide an overview of how you can get involved.
“Statement of Principles.” This document (provided in your prep packet) will be your "North Star" during the meetings and help guide your discussion. While you do not need to memorize all of this information, it will provide the basics about RLS, why more research is needed and why opioid therapies are necessary for patients with severe cases of RLS. Available for free download in the "Get Involved" section at www.rls.org.
HMCW. The Foundation has engaged HMCW staff to guide and focus advocacy efforts on behalf of the RLS community. They are available to help! Email Peter at herzog@hmcw.org with any questions or if you need additional information.

During the Meeting

What to expect. Congressional staff should be friendly and courteous. Remember, they work for you! Their goal is to help you in any way they can, and your “asks” will give them an opportunity to do so. You should arrive 15 minutes early for your meeting and dress in business casual attire. Make sure to print the leave-behind materials beforehand (provided by HMCW or available for download at www.rls.org), as you will be giving them to staff members during your meetings. Keep in mind that you will have 15–20 minutes to make your case, so be ready to start right in with the discussion.
Introductions. Start by thanking the staff member for meeting with you. Introduce yourself and talk about where you are from, then introduce everyone in the group. Be sure to keep the introductions brief so that most of your time is spent educating the representative about the needs of the RLS community. Give the staff member the leave-behind materials to reference during your discussion.
Defining RLS. The person you meet with may not know about restless legs syndrome, so it is important to define what it is. Here is a suggested explanation: “Restless legs syndrome (RLS) is a serious and chronic neurological disease. It causes unpleasant or uncomfortable sensations in the legs, together with an uncontrollable urge to move them. These symptoms can cause severe sleep loss, which can be devastating to a person’s health and well-being, and interfere with work, family and social life. There is no cure for RLS, and treatments are limited.”
Tell your RLS story. How do RLS symptoms impact you day-to-day? What challenges does RLS pose for your work, social life and family relationships? Do you have issues accessing medical care? Everyone's RLS is unique, and it's important to focus on your own experience and how RLS impacts your life.
Introduce the “asks.” Your prep packet provided by HMCW will include a sample meeting outline with specific requests, or “asks,” to make of your legislator. Make sure to review these materials before your meeting. You may want to write down some key points on a note card for reference. In the meeting, state the “asks” clearly and concisely, or read them from the document. Staffers will want to learn how their office can help you, and these “asks” are the best way for them to do so.
Responding to questions. The person you are meeting with may have some questions. If you are asked a complex question that you do not know the answer to, that is okay! Be honest. Let the staff person know that you will find the information and get back to them in a follow-up email.
In the event that you are pressed about RLS patients taking opioids, or you feel that someone is questioning or delegitimizing your struggles with RLS, remain calm and respectful. This will be rare, but it is always good to be prepared. RLS is an underdiagnosed condition, and many people are unaware of its prevalence and severity. Remind the staff person that opioid medications are a last resort for patients suffering from RLS, and that guidelines are available for physicians to prescribe them appropriately. Ask that the staff person review the written materials in the leave-behind packet, which includes the clinical guidelines (“The Appropriate Use of Opioids in the Treatment of Refractory Restless Legs Syndrome”).
Conclusion. Thank the staff member for taking the time to meet with you. The staff member will most likely give you a business card, so be sure to hang onto it for future inquiries. Consider this a relationship-building activity, and plan to follow up with the office a few times a year moving forward. If you brought a camera or phone, ask if you can step outside the office to take a picture together in front of your legislator’s nameplate, to share with the Foundation or on social media. Have fun with it!

After the Meeting

You’ve met with your legislator’s staffer, educated them about RLS, and asked them to support the needs of RLS patients. Give yourself a pat on the back for a job well done!
Make a note in your calendar to follow up by phone or email within two weeks. You can thank the staff person again for meeting with you and provide any follow-up answers to questions. This would also be a great time to plug the Foundation's website at www.rls.org, or share a clip from the Foundation’s YouTube series, My RLS Journey. You can also contact Peter Herzog at herzog@hmcw.org for help with your follow-up messages.


To read more about the Foundation's advocacy efforts, accomplishments, and how you can get involved, visit www.rls.org.

Opioid Study Still Seeking Participants

Lewis Phelps is current chair of the RLS Foundation Board of Directors. He is a strategic public relations consultant with Sitrick And Company, a Los Angeles-based firm that specializes in handling crisis situations. Previously, Phelps was head of the public relations function for the nation’s second largest electric utility and for two major U.S. rail transportation companies. Early in his career he was a staff reporter for the Wall Street Journal for 10 years.

Phelps has extensive non-profit board experience in addition to a prior six-year term on the RLS Foundation board. He has chaired United Way campaigns in two cities, co-founded an anti-litter organization in Roanoke, Virginia, was on the board and executive committee of the California Science Center for 15 years, and has served as chair of the board of Pasadena Heritage, one of the nation’s leading local historic preservation organizations.

I encourage members of the RLS community to participate in the National RLS Opioid Registry, an important new study that has been funded by the RLS Foundation and is being conducted by John Weyl Winkelman, MD, PhD, and Chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital. He is an internationally leading RLS researcher and long-standing member of the Foundation’s Scientific and Medical Advisory Board.

The study seeks to track up to 200 RLS patients who are currently being treated with an opioid medication, and who formerly were treated with a dopamine enhancing drug such as Mirapex or Requip. As of early March 2018, the study is more than halfway toward its enrollment goal.

There’s no monetary payment for participants, but the psychic rewards are large. By joining the study, you can help to significantly increase the body of scientific information that is available on the effectiveness of low dose opioids to treat RLS and the potential side effects. You can also learn how your personal experience with opioids compares with other RLS patients.

While some solid scientific studies address these questions, the Mass General study will expand our knowledge about the efficacy and safety of opioids to treat RLS. Such information will be valuable in coming months and years as the RLS Foundation grapples with the challenges that RLS patients are facing due to growing restrictions on use of opioids.

Addiction is obviously a huge and growing problem in the US. However, available clinical data suggest that using low doses of opioids to treat RLS will not contribute meaningfully to the addiction epidemic.

I can speak from personal experience in saying that participation in the RLS Registry is not difficult, time consuming, or unpleasant; I have become one of the study’s subjects. When you enroll, a researcher will conduct a 45-minute telephone interview with you, at a convenient time. They will ask about your current and former medications used to treat RLS, and your experience with them. The researcher who conducts the interviews is courteous, professional, and pleasant.

Following the initial interview, you will be asked to complete an online survey that takes about 20 minutes, and then you will be asked to complete a similar online survey every six months for up to five years. Your answers to the questions are completely confidential, and all information is kept on a secure hospital database that is only accessible by Dr. Winkelman and his research coordinator.

Each year of the study, you will receive a personal report about the overall results of the study to date, as well as a comparison of your own experience with opioids compared with the study group overall. For example, you will be informed whether your RLS symptoms are controlled better, worse, or about the same as the study group overall.

If you have RLS and are currently being treated with opioids, please do yourself and everyone else who has RLS a favor by joining the study. To do so, simply send an email to rlsregistry@partners.org, in which you identify yourself, provide contact information (email and phone number) and indicate that you wish to volunteer as a study subject.

Thanks,

Lew Phelps, Chair of the RLS Foundation Board of Directors

March 5, 2018

Giving You A Voice in Washington

By Kris Schanilec

On February 22 and 23, members of the RLS Foundation staff and leadership team traveled to Washington, DC, to advocate on behalf of the RLS community.

The delegation met with staff at the National Institutes of Health (NIH), US Food and Drug Administration (FDA), and Congress. Their goals were two-fold: to educate policy makers about RLS and the need to ensure that RLS patients continue to have access to opioid therapies; and to promote funding for RLS research that will advance better treatments and a cure.

"We are focused on making our collective voice heard in Washington to help ensure continued access to opioids as a treatment for individuals with severe cases of RLS," Executive Director Karla Dzienkowski, RN, BSN, said. "We hope to enhance and expand our advocacy efforts so that no one in our community is denied access to this critical treatment option."

For the millions of people in the US who have chronic, unrelenting, nightly RLS symptoms, opioids may offer the only hope for long-term relief, when all other treatment options have failed. If these patients lose access to opioids, they will lose the ability to manage their symptoms so that they can function in their work and social lives.

During the visit to Washington, the Foundation’s partner, the Health and Medicine Counsel of Washington (HMCW) -- a government relations organization that works with nonprofit organizations and companies in the healthcare industry -- organized opportunities for the RLS Foundation to dialogue with lawmakers, policy makers and others who influence regulations related to opioids and biomedical research.

Day 1: Meetings with NIH and FDA

On February 22, the RLS Foundation hit the ground running. Led by Dzienkowski, the RLS Foundation team included Ronald Barrett, treasurer of the Board of Directors; Dr. Christopher Earley, chair of the Foundation's Scientific and Medical Advisory Board (SMAB); Dr. Michael Silber, SMAB member and head of the Opiate Committee; Kris Schanilec, RLS Foundation communications consultant; Peter Herzog, HMCW legislative associate; and Dale Dirks, HMCW president.

"Our role here is to advocate for an open-minded view on the value of opiates in treating RLS," Dr. Earley said. "It is an important treatment option that needs to be continued and maintained, such that patients with severe RLS, if they need to use these vital medications, are not restricted in any way."

Day one included meetings with leaders of the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS), and the program staff at the FDA.

During meetings with the NHLBI and NINDS (both are institutions within the NIH), the RLSF team discussed ways to increase funding for RLS research and explored possible areas for collaboration. The NIH staff were supportive of the Foundation’s goals and offered many suggestions to explore in follow-up. “The fact that you've taken the time to network with us is a powerful statement," said Dr. Nina Schor, who is deputy director of the NINDS. “RLSF has provided vital input to NINDS in our efforts to support research that will decrease the burden of neurological illness.”

The Foundation shared the challenges of RLS patients who face limited treatment options, and the specific areas where research is needed to discover and test new therapies. The team also stressed the need for both clinical trials of opioid medications and long-term studies on their safety and effectiveness for treating severe RLS.

These meetings were important to building new relationships with individuals at the NIH who can champion the RLS cause and influence decisions about RLS research funding at the NHLBI, NINDS and other institutes within the NIH.

At the FDA, the RLS Foundation met with the office of Public Affairs and Stakeholder Engagement (PASE) at the Center for Drug Evaluation and Research (CDER) to discuss the importance of low total daily dose opioids as an RLS treatment option. The Foundation shared stories of individuals in the RLS patient community who have been taking opioid medications for decades and are encountering barriers to accessing their prescriptions. After highlighting information on new opioid treatment guidelines for patients with RLS, the team stressed the importance of safeguarding access to these medications for RLS patients who genuinely need them.

"The FDA members that we met with recognized the possibility of unintended consequences of heavy-handed restrictions on legitimate opioid use and the potential impact on RLS sufferers,” Barrett said. “Hopefully there will be positive outcomes from our meeting."

Day 2: Championing RLS on the Hill

On February 23, the RLS Foundation team met with Congressional representatives on both sides of the political aisle in 16 Senate and House offices. Meetings included staff members from the offices of Senator Joni Ernst (R-IA), Senator John Cornyn (R-TX), Senator Tina Smith (D-MN), Senator Ted Cruz (R-TX), Representative Rod Blum (R-IA), Representative Tim Walz (D-MN), Representative Roger Williams (R-TX), Representative Mike McCaul (R-TX), Senator Dianne Feinstein (D-CA), Senator Kamala Harris (D-CA), Senator Chris Van Hollen (D-MD), Senator Ben Cardin (D-MD), Representative Judy Chu (D-CA), Representative John Sarbanes (D-MD), and Representative Anna Eshoo (D-CA).

In these meetings, the RLS Foundation delegation explained the specifics of RLS and its devastating effects on the daily lives of millions of Americans. The team delivered nearly 100 letters written by RLS Foundation members, and shared stories that they hear from the RLS community about everyday struggles and increasing issues with access to opioid medications. They stressed the limitations of current treatment options, and that there is no cure for this debilitating disease.

In turn, the RLS Foundation asked that the Congressional representatives support the full $36 billion for NIH funding in fiscal year 2018 so that funds will be available for RLS research and related areas. The Foundation also encouraged the inclusion of “sleep research” as a condition eligible for research grants from the Department of Defense, so that RLS researchers will continue to be eligible for funding through this channel.

Finally, the Foundation pointed to the need for a safe harbor for RLS in any upcoming opioid-related legislation, regulations and policies, so that people with severe RLS who genuinely need opioids to manage their symptoms can continue to access these medications.

These talks were a first step in building relationships with each of the Congressional representatives, and an especially strong connection was sparked with one staffer who has a family member with RLS. The Foundation team will continue to contact these representatives in the coming months to educate them about RLS and the needs of the community.

"It was a very productive visit, and it's just the beginning of our advocacy outreach," Dzienkowski said.

This advocacy trip was an enormous stride for the RLS community and an important milestone in the Foundation’s advocacy initiative. And the fight is far from over. With the help of HMCW, the Foundation will continue to increase awareness among policy makers about the serious nature of RLS, the need for individuals with severe RLS to have access to opioids when they are the best treatment option, and the need for more funding for research that will help identify better treatments and a find cure for RLS.

Your US senators and representatives want to hear from you – their constituent. They are there to represent you. Meeting them is not difficult – it is straightforward and simply a matter of telling your story, sharing your experience and asking them to take your needs into consideration. Want to get involved? Visit the advocacy page of the RLS Foundation website to find out how you can take action now!

New guidelines for the safe use of opioids to treat RLS set forth in major medical journal

Austin, Texas, Jan. 8, 2018 – At a time of heightened national concern about opioid abuse, new guidance is available to help health care providers safely prescribe opioids to treat restless legs syndrome (RLS).

In an article published in the January issue of Mayo Clinic Proceedings , members of the Scientific and Medical Advisory Board of the Restless Legs Syndrome (RLS) Foundation provide a clinical approach for appropriate use of opioids to treat refractory RLS.

“The Appropriate Use of Opioids in the Treatment of Refractory Restless Legs Syndrome,” offers guidance to clinicians on safe and proper prescribing of opioids for RLS, how to assess patients for risk of addiction, and how to monitor opioid use over time.

Restless legs syndrome (RLS) is a chronic neurological disease characterized by an irresistible urge to move the legs, which can severely disrupt sleep. In the US, an estimated 2 to 3 percent of adults need clinical treatment for RLS.

While most RLS patients find initial relief from other medications, these medications often lose their effectiveness over time or cause serious side effects. Opioids, taken in relatively low total daily doses, can offer life-transforming relief for these patients.

“The quality of life of patients with severe RLS is very low. They have intense insomnia; they may have suicidal depression. Physicians should make appropriate use of opioids when other treatment options are ineffective,” says Michael Silber, MB ChB, a neurologist at Mayo Clinic in Rochester, Minnesota (an RLS Quality Care Center), and first author of the article. “We have published this paper so that both specialists and primary care physicians can feel more comfortable prescribing opioids to refractory RLS patients, not feel that they are at risk as physicians in treating these patients, and help relieve their suffering.”

The paper summarizes published clinical trials and case series that have shown opioids to be effective for treating RLS. The authors conclude that risk of addiction is relatively low for people who take opioids for RLS, given that much lower doses are used than for chronic pain conditions.

Recommendations include:

• Before prescribing opioids, trying strategies to improve response to other medications and considering alternative therapies.
• Assessing for risk of addiction and educating patients on responsible use. Providers are advised to have patients sign an “opioid contract” agreeing to take precautions such as not sharing the medication with others.
• Starting with the lowest dose of opioids possible, and monitoring patients over time for effectiveness and safe use.

In this video on the Mayo Clinic Proceedings YouTube channel, Dr. Silber discusses the guidelines.

The RLS Foundation is dedicated to improving the lives of men, women and children who live with restless legs syndrome. Founded in 1992, the Foundation’s goals are to increase awareness, improve treatments and through research, find a cure for RLS. The Foundation serves healthcare providers, researchers, 5,000 members and an estimated seven million individuals in the United States who have RLS. The Foundation has funded more than $1.6 million in RLS research. Learn more at www.rls.org.

Foundation Funds Study on Use of Opioids for RLS

An excerpt from the Summer 2017 edition of NightWalkers, the Foundation's quarterly magazine

The RLS Foundation has awarded a $144,000 grant to John Winkelman, MD, PhD, of Harvard Medical School, for a pilot study on the use of opioids to treat RLS. The two-year project is part of broader research to establish the long-term safety and effectiveness of opioids for treating the disease.

“This opioid registry is long overdue. It is important to establish the long-term safety and effectiveness of opioid treatment in RLS in order to distinguish it from the current literature on opioids in chronic pain,” says Christopher J. Earley, MB, BCh, PhD, FRCPI, who is chair of the RLS Foundation Scientific and Medical Advisory Board.

In the study, Dr. Winkelman and his team will recruit 200 patients from across the US who are taking opioids for RLS. The team will collect data on opiate medication and dose, severity of RLS symptoms, opiate side effects, sleep quality and augmentation. The first two years of data collection, supported by the RLS Foundation grant, will establish the parameters for ongoing, long-term research and enable the team to apply for further funding for this work.

Opioid use to treat RLS has increased over the past decade as other drugs have fallen short of meeting the needs of patients. Notably, dopamine drugs, which initially may relieve RLS symptoms, are now known to make symptoms worse over time for many people – a side effect called augmentation.

For many RLS patients, opioids are a beneficial alternative. Existing studies show that taking them at low doses can bring dramatic relief of RLS symptoms with minimal side effects.

Information is lacking about the long-term effects of opioids, however. A primary aim of the new study is to “fill that vacuum with reliable data,” says Dr. Winkelman. “In the absence of information, we have hypotheses, hunches, speculation, prejudice… And in medicine, we want to identify reliable information and data to benefit patients. The more information we have about the use of these medications in RLS, the better we’ll be able to guide patients’ decisions about the risks and benefits.”

The research also aims to address concerns in the US about using opioids to treat long-term conditions like RLS. In the midst of the nationwide opioid crisis, providers who prescribe them are under increased scrutiny, and many states have stepped up regulation.

“The concern is that some states may be so aggressive in their control of opiates that they restrict access to opiates for people who genuinely need them and are using them appropriately,” says Dr. Winkelman.

By disseminating and publishing their study results, the researchers hope to provide information for policy makers to form reasoned, scientific decisions about the use of opioid medications for RLS.

For Dr. Winkelman, this current research continues his long involvement in the field of RLS, which he says began early in his sleep medicine career when he started seeing patients with the disorder.

“There was so little known about this, and so many people who had been wandering in the wilderness of medicine, bouncing from doctor to doctor without any recognition from the medical community. The level of awareness has really grown in 25 years, and treatment options have grown as well.”

“It’s been extremely gratifying to have participated in this area of medicine over the last 25 years – see it change and be part of that change – and be a resource for patients and say to them, ‘I don’t know everything about this, but I feel secure in giving you the best information that exists.’”

John W. Winkelman, MD, PhD, is an associate 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 is also chair of the Treatment Guideline Committee for the treatment of RLS at the 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, and he was lead author on the American pivotal trial of pramipexole to treat RLS.

How to participate in the study

Recruitment for the study “Multicenter Longitudinal Pilot Observational Study of Efficacy and Tolerability of Long-Term Treatment of Restless Legs Syndrome Using Opioids” is expected to begin in late 2017. Participants will have an initial 30- to 60-minute phone interview with a clinical research team at Massachusetts General Hospital, after which they will provide information through surveys on a secure website hosted at Massachusetts General.

Information will be de-identified to protect privacy. Participants will receive an annual summary of their data, as well as a yearly newsletter summarizing all study data. If you are interested in participating in the study, watch for more information on the RLS Foundation website at www.rls.org.