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Intravenous Iron Metabolism in Restless Legs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00685815
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Restless Legs Drug: Ferric Carboxymaltose (FCM) Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Iron Metabolism in Restless Legs Syndrome
Study Start Date : November 2006
Primary Completion Date : December 2010
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Restless Legs
U.S. FDA Resources

Arms and Interventions

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
Drug: Placebo
250cc NS IV over one hour, once on Day 3, once on Day 4

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00685815     History of Changes
Other Study ID Numbers: AG0117
3P01AG021190 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Luitpold Pharmaceuticals:
IV Iron
Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs