AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prospective analysis of the therapeutic efficacy of iron isomaltoside in combination with or without dopaminergic therapy in patients with restless legs syndrome

This research trial is investigating the effectiveness of an iron treatment called iron isomaltoside for people who have restless legs syndrome (RLS). We're trying to find out if this iron treatment can significantly reduce RLS symptoms. Importantly, we're studying its effects both by itself and when given alongside other restless legs medications that patients might already be taking. The main goal is to see if symptoms improve, as measured by common RLS assessment tools. We'll also look at changes in iron levels in the blood and other body markers. This is a Phase 3 study, meaning it's a later stage trial to confirm if the treatment works and is safe for a wider group of people.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medizinische Universitaet Innsbruck

Enrolment target

140

Start

14 Oct 2024

restless leg syndrome

What is this study about?

This study is looking into a condition called Restless Legs Syndrome (RLS), which causes uncomfortable feelings in your legs and an irresistible urge to move them, especially at night. It's often linked to problems with iron levels in the body or how the body uses iron.

In this research, we're testing a special iron treatment called iron isomaltoside. You might know it by its brand name, MonoFer. We want to see how well it helps people with RLS. Specifically, we're finding out if it can make symptoms less severe. We're also checking if it works better when given on its own, or if it's more effective when used together with other common RLS medicines that affect something in the brain called dopamine.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new treatment. We're looking to confirm that the iron treatment is both safe and works well. To do this, we'll carefully measure changes in RLS symptoms and also check various things in the blood, like iron levels, to understand how the treatment affects the body. We'll even use special scans in some patients to see if iron levels in certain parts of the brain change, as this might help explain how RLS works.

Key takeaways

This study investigates an iron treatment for restless legs syndrome (RLS).
It aims to see if the iron treatment improves RLS symptoms alone or with other medicines.
It's a later-stage study (Phase 3) confirming safety and effectiveness.
Participants will receive either the iron treatment or a dummy treatment.
The study measures RLS symptom changes and monitors iron levels in the body.
Taking part helps advance understanding and potential treatments for RLS.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with restless legs syndrome. There is no upper age limit for taking part.

Both men and women are welcome to participate in this research trial. There are specific medical criteria to ensure the study is safe and effective for everyone involved, which your doctor will review with you.

Before joining, you'll have a health check to make sure the study is a good fit for you. This will help us understand your medical history and current health condition to ensure your safety throughout the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with restless legs syndrome (RLS)?
Are you able to attend regular appointments for infusions and blood tests?
Are you comfortable potentially receiving either the active iron treatment or a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the special iron treatment (MonoFer) or a dummy treatment (a saltwater solution, also called a placebo). The iron treatment is given as an infusion, which means it's slowly dripped into a vein, similar to how blood tests are taken. Your doctor will explain how many infusions you might need and how often.

Throughout the study, you'll have regular appointments where we'll ask you about your RLS symptoms using special questionnaires. We'll also take blood samples to check your iron levels and other health markers. Some participants might also have an MRI scan of their brain. The total duration of your participation, including follow-up, will be explained fully by the study team, but generally involves a period of treatment and subsequent monitoring of your health and symptoms.

Potential risks and benefits

Potential benefits of participating could include an improvement in your restless legs syndrome symptoms, and you would contribute to medical knowledge that could help many others with RLS in the future. As with any medical treatment, there are potential risks, though the iron treatment being studied is already used for other conditions. You might experience side effects, which will be carefully monitored by the study team. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is restless legs syndrome (RLS)?

RLS causes uncomfortable feelings in your legs, especially at night, and a strong urge to move them to ease the discomfort.

What is MonoFer?

MonoFer is a specific type of iron treatment that is given directly into a vein through an infusion.

Why is iron important for RLS?

Problems with iron levels in the body or how the brain uses iron are often linked to restless legs syndrome.

Will I definitely get the iron treatment?

Participants will either receive the iron treatment or a dummy treatment (placebo). You won't know which one you are getting, and neither will the study team, to keep the results fair.

How long will the study last for me?

The total time you spend in the study, including initial checks, treatment, and follow-up, will be clearly explained by the study team before you decide to join.