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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Cohort I	Cohort I	500 mg dose Venofer over 4 hours
Cohort II	Cohort II	500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7
Cohort III	Cohort III	500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale	Baseline to Day 84	Validated rating scale of RLS symptoms (Range 1 \[mild\] - 40 \[severe\])

Secondary Outcome Measures