Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Cohort I; Cohort II; Cohort III
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS
      were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron
      sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The
      second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over
      four to six hours on two separate dates, separated by two to seven days. The third cohort
      received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within
      30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed consent.

          -  Male or female subjects > 18 yrs. old.

          -  RLS signs and symptoms affirming diagnosis.

          -  A baseline score > or = to 15 is required on the International RLS Study Group Rating
             Scale (IRLSSG).

          -  At least one leg with an average baseline Periodic Leg Movement (PLM) while asleep >
             or = to 15 movements per hour by actigraphy.

          -  Subjects on dopa-adrenergic therapy or other RLS treatments must be off therapy at
             least one week before any baseline RLS assessments and actigraphy measurement are
             obtained.

          -  Subject has regular sleep hours between 9 p.m. and 9 a.m.

          -  Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be
             practicing an acceptable form of birth control.

        Exclusion Criteria:

          -  Known intolerance to Venofer.

          -  RLS which is ascribed to renal disease.

          -  RLS 2° to other CNS disease or injury.

          -  Any pain related or sleep related disorders which may confound the outcome measures.

          -  History of neuroleptic akinesia.

          -  Concurrent use of oral iron supplement.

          -  Parenteral iron use within the past 6 months.

          -  Active infection.

          -  Currently being treated for asthma.

          -  Severe peripheral vascular disease with significant skin changes.

          -  Seizure disorder currently being treated with medication.

          -  Serum ferritin level > 300 ng/mL or a TSAT > or = to 45% at baseline or a history of
             hemochromatosis.

          -  Significant cardiovascular or hepatic disease or any other pre-existing medical
             condition or disease which in the view of the investigator participation in this study
             would put the subject's disease management at risk or the subject would be unable to
             comply with the study requirements.