Intravenous Iron Metabolism in Restless Legs Syndrome



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2006
End Date:December 2012

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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.


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.
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