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

Mov. Disord. 32, 1478-1482 (2017)
DOI PMC
Open Access Green as soon as Postprint is submitted to ZB.
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.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Clinical Trial ; Ferric Carboxymaltose ; Intravenous Iron ; Iron Deficiency ; Restless Legs Syndrome; Clinical-efficacy; Double-blind; Syndrome Rls; Placebo; Augmentation; Ropinirole; Hypoxia; Safety
Reviewing status