Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
Condition: Restless Legs Syndrome; Iron Deficiency Anemia
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Syndrome
Intervention: Ferumoxytol intravenous; Ferrous sulfate
Intervention description: IV iron, 2 vials of 510 mg given 2-7 days apart; Oral iron, 325 mg tabs taken morning and evening
Intervention MeSH terms: Iron; Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the relative effect size of standard IV and oral
      iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of
      treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RLS based on questionnaire and confirmed by Hopkins telephone Diagnostic
             Interview conducted by investigators or clinicians part of the study.

          -  Iron deficiency anemia defined as ID either ferritin <20 mcg/l, Tsat <19%, anemia Hgb
             <13 for both males and females.

          -  Willingness to use contraceptive to avoid pregnancy: Women have to be surgically
             sterile, post-menopausal, or use one of the following contraceptives during the whole
             study period and after the study has ended for at least 5 times plasma biological
             half-life of the investigational medicinal product: intrauterine devices or hormonal
             contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal
             devices, or injections with prolonged release).

          -  Willingness to participate and signing the informed consent form.

        Exclusion Criteria:

          -  Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and
             haemosiderosis)

          -  Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of
             normal)

          -  Serum ferritin > 500 ng/mL or transferrin saturation >40%

          -  Active acute or chronic infections (assessed by clinical judgement that may be
             indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are
             available)

          -  Rheumatoid arthritis with symptoms or signs of active inflammation

          -  Pregnant and nursing women

          -  History of multiple allergies

          -  Known hypersensitivity to parenteral or oral iron or any excipients in the drug
             products

          -  Previous IV iron treatment for RLS

          -  Other iron treatment or blood transfusion within 4 weeks prior to the screening or
             treatment visit

          -  Planned elective surgery during the study

          -  Current (past 4 weeks) use of drugs that treat RLS, e.g. opioids, alpha-2-delta
             anti-depressants, dopaminergics (dopamine promoters, dopamine antagonists/blockers)

          -  Any other medical condition that, in the opinion of Investigator, may cause the
             subject to be unsuitable for the completion og the study or place the subject at
             potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension,
             unstable ischemic heart disease, or uncontrolled diabetes mellitus.