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Intravenous Iron Metabolism in Restless Legs Syndrome

NCT00685815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-06

Study results available
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Summary

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

Conditions

  • Restless Legs

Interventions

DRUG

Ferric Carboxymaltose (FCM)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher J. Earley, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685815 on ClinicalTrials.gov