Current Clinical Trials

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. This study is open to those with RLS and living in California, Florida, Illinois, New Jersey, New York, and Texas. Compensation available.

Visit: www.science37.net/rls-teens
Call: (310) 464-2190
Email: RLSstudy@science37.com

Posted 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 brian.koo@yale.edu or phone (203) 932-5711 ext. 5416.

Posted 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 a prescribed opioid as a treatment for symptom management. An initial brief phone interview will be followed by online surveys every 6 months for at least five years. Participants will be provided with a personal and full-sample summary of the data on a yearly basis. All data is stored anonymously in a secure electronic database.

Enrollment is limited to individuals who meet all the following criteria:

  • a diagnosis of RLS
  • are taking an opioid medication for RLS
  • have taken (or are currently taking) a dopamine agonist for RLS

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

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

Posted 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.

Iron deficiency is the most common, widespread, and costly nutritional disorder worldwide with the World Health Organization (WHO) stating that up to 2 billion people are iron deficient. There is a serious and widespread misconception that oral iron supplements are safe and effective at alleviating iron deficiency. In a recent Cochrane review of 67 clinical trials, women taking oral iron supplements had a mere 38%decreased risk of iron deficiency compared to placebo. On the contrary, these subjects had a 114%increased risk of side effects, the vast majority of which were associated with gastrointestinal (GI) disturbance.

In infants and children, iron deficiency impedes mental, motor, and auditory neuronal development leading to serious lifelong cognitive and physical deficiencies. In adults, iron deficiency, and associated iron deficiency anemia, cause extreme fatigue, decreased immune system function and increased susceptibility to infectious disease, reduced work capacity, dizziness, headaches, hair loss, and generalized reduced quality of life. Iron deficiency is also linked to Restless Leg Syndrome (RLS), adult hearing deficits, reduced strength, coordination, and endurance, anxiety, increased heart failure morbidity, decreased intellectual performance, and erectile dysfunction among many others conditions.

Most iron deficient people are not effectively treated by, or are intolerant to, oral iron supplements. Intravenous iron repletion drugs effective, but are also costly and onerous to deliver leading to both patient and payor dissatisfaction.

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.

Eligibility:
Ages Eligible for Study: 18 Years to 80 Years


Inclusion Criteria:

Moderate iron deficiency defined as transferrin saturation (TSAT) <20% and serum ferritin

Exclusion Criteria:

  • Female subjects who are pregnant, plan to become pregnant, or not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier, or intrauterine device).
  • Female subjects who are breastfeeding or plan to breastfeed after enrolling in the study.
  • Hemochromatosis or other iron storage disorders.
  • Hemoglobin below 8 g/dL.
  • Previous gastric bypass, sleeve gastrectomy, or gastric band surgery.
  • Currently on iron supplements and/or multivitamins containing iron (subjects may be pre-screened four weeks prior to the screening visit in order to stop/washout or switch to vitamins not containing iron). Currently on monoamine oxidase inhibitors (MAOIs) or Demerol.
  • Current diagnosis of asthma and is actively using anti-asthmatic therapy.
  • Smoking within two weeks of screening, current smoking, or anticipated smoking after enrolling in the study.
  • Active malignancy within one year of screening.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal.
  • Known positive Hepatitis B, Hepatitis C, or HIV-1/HIV-2.

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

Posted March 2016

Does your child have discomfort in their legs that may interfere with their sleep? They may describe their symptoms as throbbing, pulling, creeping, pain or other abnormal sensations felt in the legs when lying down or sitting. Your child may be suffering from adolescent Restless legs Syndrome.

Worldwide Clinical Trials is conducting research studies to test an investigational medication for the treatment of adolescent RLS. You will receive the medication at no charge, an assessment by an RLS expert and compensation for participating in this research clinical trial. The studies will take place at the following locations Amherst (NY), Columbia (SC), Indianapolis (IN), Nashville (TN), Philadelphia (PA), Redwood City (CA), and San Diego (CA). Qualified participants will be compensated for time and travel. To qualify, participants must:

  • be 13-17 years of age
  • be diagnosed with RLS
  • have moderate-to-severe symptoms
  • have parent/legal guardian consent

If you are interested in learning more about this study, or to find out if you qualify call (520)-252-1908 or email Camilla.Alexander@wwctrials.com.

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 Jose.Martinez@nyumc.org.

Further Reading

Clinical Trails: What to Know Before You Go

Inside: Important Information for those considering clinical trail participation

Read More