Intravenous Iron Metabolism in Restless Legs Syndrome

This study has been completed.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: May 23, 2008
Last updated: July 23, 2015
Last verified: July 2015
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

Condition Intervention Phase
Restless Legs
Drug: Ferric Carboxymaltose (FCM)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Iron Metabolism in Restless Legs Syndrome

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Patient's subjective report of significant RLS symptoms, obtained in a standard clinical interview [ Time Frame: at 2 and 4 weeks after IV iron, and monthly thereafter for 2 years or until oral meds resumed ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
250cc NS IV over one hour, once on Day 3, once on Day 4


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00685815

United States, Maryland
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Luitpold Pharmaceuticals
National Institute on Aging (NIA)
Principal Investigator: Christopher J. Earley, MD, PhD Johns Hopkins University
  More Information

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00685815     History of Changes
Other Study ID Numbers: AG0117  3P01AG021190  1VIT06013 
Study First Received: May 23, 2008
Last Updated: July 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
IV Iron
Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 23, 2016