Intravenous Iron Metabolism in Restless Legs Syndrome (RLS)

American Regent

Status and phase

Completed

Phase 2

Conditions

Restless Legs

Treatments

Drug: Ferric Carboxymaltose (FCM)

Drug: Placebo

Study type

Interventional

Funder types

Industry

NIH

Identifiers

AG0117

3P01AG021190 (U.S. NIH Grant/Contract)

1VIT06013

Details and patient eligibility

About

Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome

Full description

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.