Clinical Trials Directory

Trials / Completed

CompletedNCT00685815

Intravenous Iron Metabolism in Restless Legs Syndrome

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
12 (actual)
Sponsor
American Regent, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGFerric Carboxymaltose (FCM)500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
DRUGPlacebo250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Timeline

Start date
2006-11-01
Primary completion
2010-12-01
Completion
2012-12-01
First posted
2008-05-28
Last updated
2025-05-06
Results posted
2025-05-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00685815. Inclusion in this directory is not an endorsement.