CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Not stated in 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/NCT01382901
NCT01382901Phase 2Completed
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A Phase 2a Study Evaluating the Efficacy and Safety of a Novel Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

American Regent, Inc.·interventional·Posted Jun 27, 2011·Updated Feb 20, 2018

In Brief

A Phase 2 clinical trial evaluating Ferric Carboxymaltose (FCM) and Placebo for Restless Legs Syndrome (RLS). Completed, enrolled 45 participants.

Detailed Summary

The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome (RLS)
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2011
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.0 years ago

Interventions

Ferric Carboxymaltose (FCM)drug

Placebodrug