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

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.