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

Study Overview
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Brief Summary
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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.

Official Title
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Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Cohort I
* Drug: Cohort II
* Drug: Cohort III


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I<br>500 mg dose Venofer over 4 hours | Drug: Cohort I<br> <br> * Other names: iron sucrose injection - Venofer;|
| Experimental: Cohort II<br>500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 | Drug: Cohort II<br> <br> * Other names: iron sucrose injection - Venofer;|
| Experimental: Cohort III<br>500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours | Drug: Cohort III<br> <br> * Other names: iron sucrose injection - Venofer;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) | Quantifies amount of leg movement | Baseline to Day 84 |