Intravenous Iron Metabolism in Restless Legs Syndrome

NCT ID: NCT00685815

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Restless Legs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ferric carboxymaltose (FCM)

Intravenous iron (FCM)

Group Type: EXPERIMENTAL

Ferric Carboxymaltose (FCM)

Intervention Type: DRUG

500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Placebo

normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Interventions

Ferric Carboxymaltose (FCM)

500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Intervention Type: DRUG

Placebo

250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Intervention Type: DRUG

Other Intervention Names

Injectafer

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J. Earley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

3P01AG021190

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1VIT06013

Identifier Type: OTHER

Identifier Source: secondary_id

AG0117

Identifier Type: -

Identifier Source: org_study_id