Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT02484768
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of RLS based upon the CH-RLSq and HTDI
3. IRLS score ≥ 15 at baseline evaluation when off RLS medications
4. Willingness to participate and signing the informed consent form
Exclusion Criteria:
1. S-ferritin \> 300 ng/mL and/or TfS \> 50 %
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
3. Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts
4. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
5. History of active asthma within the last 5 years
6. Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT \> 3 times upper limit of normal)
7. Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)
8. Rheumatoid arthritis with symptoms or signs of active inflammation
9. Pregnant or nursing women
10. Previous IV iron treatment for RLS
11. IV iron treatment within 1 year prior to screening
12. Blood transfusion within 4 weeks prior to screening
13. Planned elective surgery during the study
14. Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening
15. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. history of multiple allergies, a malignancy, uncon-trolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes melli-tus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02484768
Study Brief:
Protocol Section:
NCT02484768