Intravenous Iron Metabolism in Restless Legs Syndrome
Phase 2
Completed
- Conditions
- Restless Legs
- Interventions
- Drug: Ferric Carboxymaltose (FCM)Drug: Placebo
- Registration Number
- NCT00685815
- Lead Sponsor
- American Regent, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ferric carboxymaltose (FCM) Ferric Carboxymaltose (FCM) Intravenous iron (FCM) Placebo Placebo normal saline
- Primary Outcome Measures
Name Time Method Duration Off Treatment 2 weeks, 4 weeks, and 52 weeks Number of weeks that patients were able to remain off treatment for RLS
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States