Intravenous Iron Metabolism in Restless Legs Syndrome

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Collaborator: National Institute on Aging (NIA)
• Treatments: 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.