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| Study 5 of 33 for search of: | nia OR national institute on aging | received from 03/31/2008 to 03/31/2009 |
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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborator: |
Luitpold Pharmaceuticals |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00685815 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Intravenous Iron Metabolism in Restless Legs Syndrome |
| 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 |
|---|---|
|
24 participants: Experimental
Intravenous Iron (FCM)
|
Drug: Ferric Carboxymaltose (FCM)
500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
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12 participants: Placebo Comparator
Placebo
|
Drug: Placebo
250cc NS IV over one hour, once on Day 3, once on Day 4
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| The Johns Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Christopher J. Earley, MD, PhD | Johns Hopkins University |
More Information
| Responsible Party: | Luitpold Pharmaceuticals, Inc. ( Angie Butcher ) |
| Study ID Numbers: | AG0117, 3P01AG021190, 1VIT06013 |
| Study First Received: | May 23, 2008 |
| Last Updated: | April 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00685815 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
IV Iron Restless Legs Syndrome RLS Iron |
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Disease Nervous System Diseases Parasomnias Dyssomnias Sleep Disorders Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Restless Legs Syndrome Psychomotor Disorders Neurologic Manifestations Neurobehavioral Manifestations |