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Prospective analysis of the therapeutic efficacy of iron isomaltoside in combination with or without dopaminergic therapy in patients with restless legs syndrome
EU CTIS ID: 2024-512117-40-00
What this study is testing
Main objective of this study is to investigate the effect of iron supplementation or placebo (in combination or not with dopaminergic therapy) on clinical RLS symptoms measured by the IRLS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- RLS diagnosed according to the current IRLSSG criteria Essential diagnostic criteria (all must be met): a) An urge to move the legs usually but not always accompanied by, or felt to be caused by, uncomfortable and unpleasant sensation in the legs. b) The urge to move the legs and any accompanying unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting c) The urge to move the legs and any accompanying unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. d) The urge to move the legs and any accompanying unpleasant sensations during rest or inactivity only occur or are worse in the evening or night than during the day. d) The occurence of the above features is not solely accounted for as symptoms primary to another medical or a behavioral condition (e.g. myalgia, venous stasis, leg edema, arthritis, leg cramps, positional discomfort, habitual foot tapping).
- Female and male participants aged ≥ 18 years
- Negative urine/serum pregnancy test in women of childbearing potential (WOCBP). WOCBP who are sexually active, agree to use highly effective means of contraception during the study and for at least 1 month post-study treatment. Allowed are accepted and effective hormonal/non-hormonal methods of contraception and sexual abstinence or vasectomised partners (> 3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
- IRLS score >=15
- For the DA group, DA dosage not exceeding the max recommended dosage for RLS (PMID 27448465): Pramipexole 0.75 mg/day, Ropinirole 4mg/day, Rotigotine 3 mg/day
- Written, signed and dated informed consent
You likely can't join if
- Secondary RLS
- Malignancies
- Pregnancy/brestfeeding
- Known thalassaemia minima/minor, hemochromatosis, polycythemia vera, hemolytic anemia
- Iron substitution, erythropoietin therapy or blood transfusion in the previous 6 months
- Ferritin > 300 mg/dL or Transferrin Saturation over 45%
See the full eligibility criteria
Who can join
- RLS diagnosed according to the current IRLSSG criteria Essential diagnostic criteria (all must be met): a) An urge to move the legs usually but not always accompanied by, or felt to be caused by, uncomfortable and unpleasant sensation in the legs. b) The urge to move the legs and any accompanying unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting c) The urge to move the legs and any accompanying unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. d) The urge to move the legs and any accompanying unpleasant sensations during rest or inactivity only occur or are worse in the evening or night than during the day. d) The occurence of the above features is not solely accounted for as symptoms primary to another medical or a behavioral condition (e.g. myalgia, venous stasis, leg edema, arthritis, leg cramps, positional discomfort, habitual foot tapping).
- Female and male participants aged ≥ 18 years
- Negative urine/serum pregnancy test in women of childbearing potential (WOCBP). WOCBP who are sexually active, agree to use highly effective means of contraception during the study and for at least 1 month post-study treatment. Allowed are accepted and effective hormonal/non-hormonal methods of contraception and sexual abstinence or vasectomised partners (> 3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
- IRLS score >=15
- For the DA group, DA dosage not exceeding the max recommended dosage for RLS (PMID 27448465): Pramipexole 0.75 mg/day, Ropinirole 4mg/day, Rotigotine 3 mg/day
- Written, signed and dated informed consent
What rules you out
- Secondary RLS
- Malignancies
- Pregnancy/brestfeeding
- Known thalassaemia minima/minor, hemochromatosis, polycythemia vera, hemolytic anemia
- Iron substitution, erythropoietin therapy or blood transfusion in the previous 6 months
- Ferritin > 300 mg/dL or Transferrin Saturation over 45%
- Phosphate levels below the lower limit normal before study drug initiation
- Contraindications for performing a MRI (for example claustrophobia, pacemakers, metal implants)
- Body weight < 50 kg
- Known Hypersensitivity to the active substance or any of its excipients (Sodium hydroxide/Hydrochloric acid
- Sporadic RLS
- Dialysis-dependent renal failure (eGFR<20mL/min/1.73m² calculated by MDRD formula)
- Moderate or severe heart failure (NYHA III - IV)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.