Expired Study
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Baltimore, Maryland 21224


Purpose:

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


Criteria:

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.


NCT ID:

NCT00685815


Primary Contact:

Principal Investigator
Christopher J. Earley, MD, PhD
Johns Hopkins University


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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