Phase 2 N=93 Randomized Triple-blind Treatment

Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)

Restless Legs Syndrome · Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT02499354 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change From Baseline in the Restless Legs Syndrome Rating Scale — -14.0000; -9.7353 units on a scale — p=0.2742

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ferumoxytol intravenous (Drug); Ferrous sulfate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Auerbach Hematology Oncology Associates P C
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Restless Legs Syndrome Rating Scale	-14.0000; -9.7353	0.2742
PRIMARY Percentage of Participants With Improvement on Clinical Global Impression Scale	75; 68	0.55
SECONDARY Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	22; 11	—

Summary

The purpose of the study is to determine the relative effect size of standard IV and oral iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of treatment response.

Eligibility Criteria

Inclusion Criteria

Diagnosis of RLS based on questionnaire and confirmed by Hopkins telephone Diagnostic Interview conducted by investigators or clinicians part of the study.
Iron deficiency anemia defined as ID either ferritin 3 times upper limit of normal)
Serum ferritin > 500 ng/mL or transferrin saturation >40%
Active acute or chronic infections (assessed by clinical judgement that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnant and nursing women
History of multiple allergies
Known hypersensitivity to parenteral or oral iron or any excipients in the drug products
Previous IV iron treatment for RLS
Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
Planned elective surgery during the study
Current (past 4 weeks) use of drugs that treat RLS, e.g. opioids, alpha-2-delta anti-depressants, dopaminergics (dopamine promoters, dopamine antagonists/blockers)
Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion og the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02499354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.