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
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
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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 May 22, 2013