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Study on the Effects of Ferric Derisomaltose and Dopaminergic Therapy for Patients with Restless Legs Syndrome

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Restless Legs Syndrome (RLS), a condition that causes an uncontrollable urge to move the legs, usually due to uncomfortable sensations. The study will explore the use of a medication called ferric derisomaltose, which is a form of iron given through an injection or infusion. This treatment will be tested alone or in combination with dopaminergic therapy, which involves medications that affect dopamine, a chemical in the brain that helps control movement.

The purpose of the study is to investigate how iron supplementation or a placebo, with or without dopaminergic therapy, affects the symptoms of RLS. Participants will receive either the iron treatment or a placebo, and some may also receive dopaminergic therapy. The study will monitor changes in the severity of RLS symptoms over time. Participants will be given the treatment through an intravenous infusion, which means the medication is delivered directly into a vein.

Throughout the study, various health indicators will be monitored, including blood tests to check levels of iron and other substances in the body. Some participants may also undergo an MRI scan, a type of imaging test, to look at iron content in a specific part of the brain. The study aims to provide insights into how these treatments can help manage RLS symptoms and improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the trial's purpose and procedures. Written, signed, and dated informed consent is required to confirm understanding and agreement to participate.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes a diagnosis of restless legs syndrome (RLS) based on specific criteria, such as an urge to move the legs, especially during rest, and relief through movement.
Women of childbearing potential will need to provide a negative pregnancy test and agree to use effective contraception during the study and for at least one month after.
Step 3
Treatment phase
Participants will receive either iron supplementation or a placebo. The iron is administered as ferric derisomaltose through an intravenous infusion. The exact dosage and frequency will be determined by the study protocol.
Some participants may also receive dopaminergic therapy with medications such as Pramipexole, Ropinirole, or Rotigotine, not exceeding the maximum recommended dosage for RLS.
Step 4
Monitoring and follow-up
Throughout the study, participants will be monitored for changes in RLS symptoms using the International Restless Legs Syndrome Rating Scale (IRLS).
Additional tests may include blood tests to measure various health indicators and, for some participants, an MRI to assess iron content in specific brain areas.
Step 5
Completion of the study
Upon completing the study, participants will have a final assessment to evaluate the effects of the treatment on RLS symptoms.
Participants will be informed about the study's findings and any implications for their health.

Who can join the trial?

12 criteria

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Must have restless leg syndrome (RLS) diagnosed according to specific criteria. This includes:
- An urge to move the legs, usually with uncomfortable sensations in the legs.
- The urge and sensations start or get worse during rest or inactivity, like sitting or lying down.
- These feelings are relieved by movement, such as walking or stretching.
- The symptoms are worse in the evening or night than during the day.
- The symptoms are not due to another medical or behavioral condition.
- Participants must be 18 years or older.
- Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for at least one month after.
- Must have an IRLS score of 15 or higher. (IRLS is a scale used to measure the severity of RLS symptoms.)
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  If taking dopaminergic therapy (medication for RLS), the dosage must not exceed the recommended maximum:
  - Pramipexole: 0.75 mg per day
  - Ropinirole: 4 mg per day
  - Rotigotine: 3 mg per day
  - Must provide written, signed, and dated informed consent to participate in the study.

Who cannot join the trial?

9 criteria

Patients who are not within the age range of 18 to 65 years old cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with severe kidney disease cannot participate. Severe kidney disease means the kidneys are not working well enough to filter waste from the blood.
Patients with a history of iron overload disorders are excluded. Iron overload disorders are conditions where the body stores too much iron, which can be harmful.
Patients who have had a recent heart attack or stroke cannot participate. A heart attack is when blood flow to the heart is blocked, and a stroke is when blood flow to the brain is interrupted.
Patients with uncontrolled high blood pressure are not eligible. Uncontrolled high blood pressure means blood pressure that is not managed well with treatment.
Patients who are currently participating in another clinical trial are excluded.
Patients with known allergies to iron supplements cannot participate.
Patients with a history of certain psychiatric disorders are not eligible. Psychiatric disorders are mental health conditions that affect mood, thinking, and behavior.

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Medizinische Universitaet Innsbruck
Innsbruck, Austria

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Investigated drugs

Iron Isomaltoside
is a type of iron supplement used in this clinical trial. It is designed to help increase the levels of iron in the body. Iron is an essential mineral that helps your body produce red blood cells, which carry oxygen throughout your body. In this study, the researchers are looking at how iron isomaltoside might help improve symptoms of restless legs syndrome, a condition that causes uncomfortable sensations in the legs and an irresistible urge to move them.
Dopaminergic Therapy
refers to treatments that involve medications affecting dopamine, a chemical in the brain that helps control movement and emotional responses. In this trial, dopaminergic therapy is being used to see if it can help reduce the symptoms of restless legs syndrome when used alone or in combination with iron isomaltoside. Dopamine-related treatments are often used to manage conditions that involve movement disorders, and the researchers are exploring their potential benefits for people with restless legs syndrome.

What is already known about the treatment

Iron Isomaltoside – Iron isomaltoside is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied for its effectiveness in treating restless leg syndrome (RLS), a condition that causes an uncontrollable urge to move the legs. The main therapeutic use of iron isomaltoside in this context is to alleviate symptoms of RLS, potentially by addressing iron deficiency, which is thought to play a role in the condition. At the molecular level, iron isomaltoside works by replenishing iron stores in the body, which is essential for various bodily functions, including the production of dopamine, a neurotransmitter involved in movement. It is classified as an iron supplement in pharmacology.

Investigated diseases

Restless Legs Syndrome – Restless Legs Syndrome is a neurological disorder characterized by an uncontrollable urge to move the legs, usually due to uncomfortable sensations. These sensations often occur in the evening or nighttime hours when a person is sitting or lying down. The condition can lead to difficulties in falling or staying asleep, which can result in daytime fatigue. The sensations are typically described as creeping, crawling, tingling, or burning. Movement, such as walking or stretching, often temporarily relieves the discomfort. The severity of symptoms can vary from mild to intolerable and may fluctuate in intensity.