Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments

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.