Intravenous Iron Metabolism in Restless Legs Syndrome

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

Study Overview

• Status: Completed
• Conditions: Restless Legs
• Intervention / Treatment: Drug: Ferric Carboxymaltose (FCM); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • The Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24 participants; Intravenous Iron (FCM)	Drug: Ferric Carboxymaltose (FCM); 500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
Placebo Comparator: 12 participants; Placebo	Drug: Placebo; 250cc NS IV over one hour, once on Day 3, once on Day 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's subjective report of significant RLS symptoms, obtained in a standard clinical interview	at 2 and 4 weeks after IV iron, and monthly thereafter for 2 years or until oral meds resumed

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Christopher J. Earley, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Iron; Restless Legs Syndrome; RLS; IV Iron
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: AG0117; 3P01AG021190 (U.S. NIH Grant/Contract); 1VIT06013