Intravenous Iron Metabolism in Restless Legs Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00685815
First received: May 23, 2008
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

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

National Institute on Aging (NIA) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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 National Institute on Aging (NIA):

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 ]

Estimated Enrollment: 36
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
Estimated 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
Placebo
Drug: Placebo
250cc NS IV over one hour, once on Day 3, once on Day 4

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685815

Locations
United States, Maryland
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Principal Investigator: Christopher J. Earley, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Angie Butcher, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00685815     History of Changes
Other Study ID Numbers: AG0117, 3P01AG021190, 1VIT06013
Study First Received: May 23, 2008
Last Updated: April 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
IV Iron
Restless Legs Syndrome
RLS
Iron

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014