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Iron Supplement

IV Iron for Restless Legs Syndrome

Phase 2
Waitlist Available
Led By Michael Auerbach, MD
Research Sponsored by Auerbach Hematology Oncology Associates P C
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after treatment
Awards & highlights

Study Summary

This trial is testing if IV or oral iron is better to treat RLS with IDA, and how long it takes for the treatment to work.

Eligible Conditions
  • Restless Legs Syndrome
  • Iron-Deficiency Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 6 weeks after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 6 weeks after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Restless Legs Syndrome Rating Scale
Percentage of Participants With Improvement on Clinical Global Impression Scale
Secondary outcome measures
Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.
Other outcome measures
Number of Participants with Adverse Events Judged Related or Possibly Related to Treatment.

Trial Design

2Treatment groups
Active Control
Group I: IV IronActive Control1 Intervention
Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart
Group II: Oral IronActive Control1 Intervention
Ferrous Sulfate 325mg (oral) tabs morning and evening

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Industry Sponsor
43 Previous Clinical Trials
11,266 Total Patients Enrolled
Auerbach Hematology Oncology Associates P CLead Sponsor
4 Previous Clinical Trials
340 Total Patients Enrolled
Michael Auerbach, MDPrincipal Investigator - Auerbach Hematology and Oncology Associates, PC
Auerbach Hematology Oncology Associates P C, MedStar Franklin Square Medical Center
New York Medical College (Medical School)
Cleveland Clinic Fndn (Residency)
2 Previous Clinical Trials
134 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
Michael Auerbach MD 2014. "Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02499354.
~9 spots leftby Apr 2025
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