CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00685815
NCT00685815Phase 2Completed

Intravenous Iron Metabolism in Restless Legs Syndrome

American Regent, Inc.·interventional·Posted May 28, 2008·Updated May 6, 2025

In Brief

A Phase 2 clinical trial evaluating Ferric Carboxymaltose (FCM) and Placebo for Restless Legs. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2008
Enrollment StartNov 1, 2006
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.1 years ago

Interventions

Ferric Carboxymaltose (FCM)drug

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

Placebodrug

250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4