Status:
COMPLETED
Intravenous Iron Metabolism in Restless Legs Syndrome
Lead Sponsor:
American Regent, Inc.
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Restless Legs
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
Detailed Description
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.
Eligibility Criteria
Inclusion
- Clinical diagnosis of Restless Legs Syndrome (RLS).
- Presence of increased periodic leg movements of sleep (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
- 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 magnetic resonance imaging (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, systemic lupus erythematosus). This is to exclude conditions which will potentially alter iron metabolism.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00685815
Start Date
November 1 2006
End Date
December 1 2012
Last Update
May 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224