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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00685815 |
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Date of registration:
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23/05/2008 |
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Primary sponsor: |
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Public title:
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Intravenous Iron Metabolism in Restless Legs Syndrome
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Scientific title:
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Intravenous Iron Metabolism in Restless Legs Syndrome |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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36 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00685815 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher J. Earley, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Restless Legs
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Intervention(s)
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Drug: Ferric Carboxymaltose (FCM)
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary ID(s)
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1VIT06013
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3P01AG021190
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AG0117
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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