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Iron Supplement

Injectafer for Restless Legs Syndrome

Phase 2
Waitlist Available
Research Sponsored by American Regent, Inc.
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 baseline to day 42

Summary

Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA). Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS symptoms worsen or reoccur.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: InjectaferActive Control1 Intervention
750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM)
Group II: Normal SalinePlacebo Group1 Intervention
Placebo (15 ml of Normal Saline \[NS\]) IV push at 2 ml/minute on Day 0 and 7.

Find a Location

Who is running the clinical trial?

American Regent, Inc.Lead Sponsor
60 Previous Clinical Trials
19,045 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
311 Patients Enrolled for Restless Legs Syndrome
~8 spots leftby Nov 2025
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