Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21224


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.



Primary Contact:

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

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.