IV Iron Treatment of Restless Legs Syndrome

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