Ferric carboxymaltose in patients with restless legs syndrome and nonanemic iron deficiency: A randomized trial

on behalf of the FCM-RLS Study Investigators

Research output: Contribution to journalArticlepeer-review

53 Scopus citations

Abstract

Background: Compromised iron status is important in restless legs syndrome pathophysiology. We compared the efficacy and tolerability of ferric carboxymaltose (single intravenous dose) versus placebo for restless legs syndrome treatment in iron-deficient nonanemic patients. Methods: Patients with moderate to severe restless legs syndrome and serum ferritin < 75 μg/L (or serum ferritin 75-300 μg/L and transferrin saturation < 20%) were randomized to ferric carboxymaltose (1000 mg iron) or placebo. Mean change difference between ferric carboxymaltose and placebo in International Restless Legs Syndrome Severity Scale score from baseline to week 4 was the primary end point; week 12 was a secondary end point. Results: Ferric carboxymaltose treatment (n = 59) led to nonsignificant improvement over placebo (n = 51) in International Restless Legs Syndrome Severity Scale score at week 4 (difference [95% confidence interval], -2.5 [-5.93 to 1.02], P = 0.163), reaching significance by week 12 (-4.66 [-8.59 to -0.73], P = 0.021). Conclusions: In patients who responded to treatment, ferric carboxymaltose may require more time to stabilize restless legs syndrome than previously assumed.

Original languageEnglish
Pages (from-to)1478-1482
Number of pages5
JournalMovement Disorders
Volume32
Issue number10
DOIs
StatePublished - Oct 2017

Keywords

  • clinical trial
  • ferric carboxymaltose
  • intravenous iron
  • iron deficiency
  • restless legs syndrome

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