Intravenous Iron Metabolism in Restless Legs Syndrome

Study Overview
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Brief Summary
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To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

Official Title
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Intravenous Iron Metabolism in Restless Legs Syndrome

Conditions
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Restless Legs

Intervention / Treatment
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* Drug: Ferric Carboxymaltose (FCM)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Restless Legs Syndrome (RLS). Presence of increased PLMS before receiving treatment. Patient sleep times are between 9pm and 9am. Patient's RLS symptoms would occur daily if you were not on medication. Exclusion Criteria: RLS secondary to other medical disorders as determined by history and physical/neurological examination. On a treatment (e.g., psychiatric medication) that might significantly alter RLS symptoms or study results and who cannot discontinue medication for the extended period of the study. History of multiple adverse drug reactions or specifically an allergy to IV iron. Currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation. An MRI is not possible because of medical reasons (Pacemaker; loose iron in the tissue) or concern about severe claustrophobia. Any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy). Serum ferritin >300mg/L or percent iron saturation >50%. This is to exclude subjects with probable hemochromatosis. Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, SLE). This is to exclude conditions which will potentially alter iron metabolism.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24 participants<br>Intravenous Iron (FCM) | Drug: Ferric Carboxymaltose (FCM)<br>* 500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4<br>|
| Placebo Comparator: 12 participants<br>Placebo | Drug: Placebo<br>* 250cc NS IV over one hour, once on Day 3, once on Day 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's subjective report of significant RLS symptoms, obtained in a standard clinical interview |  | at 2 and 4 weeks after IV iron, and monthly thereafter for 2 years or until oral meds resumed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV Iron, Restless Legs Syndrome, RLS, Iron