Treatment for Restless Legs Syndrome

Recruiting · 18+ · All Sexes · South Dartmouth, MA

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

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About the trial for Restless Legs Syndrome

Eligible Conditions
Syndrome · Restless Legs Syndrome · Restless Legs Syndrome (RLS) · Psychomotor Agitation · Anemia, Iron-Deficiency

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Control Group 1
Placebo (Normal Saline)
Control Group 2
Injectafer® (Ferric Carboxymaltose - FCM)


This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects who may become pregnant are required to have a negative pregnancy test before starting the study, use an effective form of birth control, have had a hysterectomy or tubal ligation, or be otherwise unable to become pregnant show original
People who want to participate in a study on sleep medication must have been taking the same dose of medication for at least six months before screening. show original
The individual has a score of 15 or higher on the IRLSS, experiences symptoms of RLS for at least 3 months, and currently experiences the symptoms at least 2 nights per week. show original
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Odds of Eligibility
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 42
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 42.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes in patients with Restless Legs Syndrome. Measurement will happen over the course of Baseline to Day 42.

Treatment Phase I: IRLSS score change
IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.
Treatment Phase I: CGI-I
DAY 42
CGI-I (Clinical Global Impression- Improvement) at Day 42.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is restless legs syndrome?

There was a strong link between restless legs syndrome and insomnia that was not previously known or expected. This relationship, whether causal or not, could have a role in future treatment options. This is a very challenging disorder that [needs to be studied deeper to determine potential treatments ( and/or treatments (] which should be made available to you. When one is looking to join a Restless legs clinical trial, [Power](http://www.withpower.

Anonymous Patient Answer

What are common treatments for restless legs syndrome?

Given the limited evidence, common therapies for restless legs syndrome include sleep aids, nonbenzodiazepines, stimulants, and antipsychotic agents. No therapies are supported by strong evidence, with many needing further investigation. The most effective strategy for relieving symptoms at least temporarily may be the reduction of sleep fragmentation.

Anonymous Patient Answer

Can restless legs syndrome be cured?

There currently is no cure for RLS, but many treatments have proven useful, for example, in alleviating the subjective symptoms and improving the quality of life, and many medications have been effective in the last 15 years. The disease, however, has a high remission rate and, for many patients, a good quality of life with excellent symptom control, and no significant long-term adverse effects of medication. The aim of this paper is to give an overview of the treatment options for RLS, to compare them and provide the evidence to support treatment decisions.

Anonymous Patient Answer

How many people get restless legs syndrome a year in the United States?

About 3 million Americans currently have this syndrome according to the data compiled by the RLS Foundation. This results in considerable distress to the affected person and significant economic and social costs.

Anonymous Patient Answer

What are the signs of restless legs syndrome?

Signs and symptoms of RLS are typically intermittent, with symptoms not being noticed outside of the patient's normal waking hours. Patients tend to avoid activity and rest until they recognize their symptoms. The main symptom is a strong urge to move the legs. Some patients with RLS experience muscle cramping, numbness, and even itching, particularly with activity or exertion. The risk of developing RLS increases in people who are older, have insomnia, and have other health problems such as Parkinson's disease or a neurological disorder. RLS most commonly affects women in their 40s and 60s. Approximately 50% of affected patients initially present with an identifiable primary cause for symptoms.

Anonymous Patient Answer

What causes restless legs syndrome?

In many cases, RLS cannot be completely explained by medical, behavioral, and psychological factors alone. These data indicate that the genetic predisposition, metabolic abnormalities, and environmental toxins may operate in combination to produce RLS.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Many subjects prescribed medications in conjunction with other treatments reported good or excellent improvements in sleepiness symptoms. Results from a recent clinical trial could affect the choice of appropriate treatments for RLS.

Anonymous Patient Answer

How does treatment work?

Results from a recent clinical trial suggest that the efficacy of CBT in patients with RLS is not limited to a single type of treatment method(s) but may actually be correlated to the patient's current level of pain and the degree of interference with everyday activities. Results from a recent clinical trial are of importance to inform those with RLS in managing their disease and in designing new therapeutic strategies that may help to preserve quality of life.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Recent findings of the present study indicate that there are no significant differences in improvement between the placebo and drug groups. However, if the drug is used, the therapeutic effect is significantly more effective than a placebo, and treatment of RLS patients with amitriptyline can be recommended.

Anonymous Patient Answer

Who should consider clinical trials for restless legs syndrome?

Many of these patients should consider clinical trials for RLS because a cure has not been found. The lack of effective treatments for chronic RLS is a public health concern. These patients are at high risk to develop other co-morbid conditions. The health impact of RLS should continue to be a prominent component of the focus of RLS clinical trials and their design and analysis should continue to be refined.

Anonymous Patient Answer

What does treatment usually treat?

Treating restless legs syndrome with iron supplements in addition to levodopa did not relieve the underlying problem nor reduce the frequency of restless legs. There was significant iron deficiency among the restless legs group.

Anonymous Patient Answer

Does treatment improve quality of life for those with restless legs syndrome?

Recent findings show that these patients with RLS find improvement in HRQOL after treatment with pramipexole, a drug currently available under the brand name Extension. This improvement is similar to the improvement that patients with RLS can expect in clinical trials of other treatments for RLS, confirming that patients in clinical trials and those receiving the treatment do expect improvements in HRQOL. Despite these improvements in HRQOL, the level of patient satisfaction with treatment was low. In addition, improvement in HRQOL may require a longer time course of treatment than previously thought.

Anonymous Patient Answer
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