Evidence map›Paper›PMID 28643901›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2017

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

Claudia Trenkwalder, Juliane Winkelmann, Wolfgang Oertel, Garth Virgin, Bernard Roubert, Anna Mezzacasa, FCM-RLS Study Investigators

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Intravenous iron therapy for non-anaemic, iron-deficient adults.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Iron for the treatment of restless legs syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
  6. Altered iron metabolism and iron therapy in restless legs syndrome.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  7. Review
  8. The evolving treatment landscape of restless legs syndrome.Therapeutic advances in neurological disorders · 2026
    Review
  9. Review
  10. Review
  11. Serum ferritin measurements differ according to the assay used: implications for iron therapy in restless legs syndrome.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Restless Legs Syndrome: Contemporary Diagnosis and Treatment.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Claudia TrenkwalderDepartment of Neurosurgery, University Medical Center, Göttingen, Germany.
Juliane WinkelmannNeurologische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Wolfgang OertelInstitut für Neurogenomik, Helmholtz Zentrum München, Munich, Germany.
Garth VirginVifor Pharma, Glattbrugg, Switzerland.
Bernard RoubertVifor Pharma, Glattbrugg, Switzerland.
Anna MezzacasaVifor Pharma, Glattbrugg, Switzerland.
FCM-RLS Study Investigators
Vifor Pharma (Switzerland) · CHKlinikum rechts der Isar · DEPhilipps University of Marburg · DEUniversitätsmedizin Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCompromised 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.

methodsPatients 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.

resultsFerric 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).

conclusionsIn patients who responded to treatment, ferric carboxymaltose may require more time to stabilize restless legs syndrome than previously assumed. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Indexed as

AgedAged, 80 and overFemaleFerric CompoundsFerritinsHematinicsHumansIron Metabolism DisordersMaleMaltoseMiddle AgedProspective StudiesRestless Legs SyndromeSingle-Blind MethodTime FactorsTreatment Outcomeferric carboxymaltoseFerric CompoundsFerritinsHematinicsMaltoseclinical trialferric carboxymaltoseintravenous ironiron deficiencyrestless legs syndrome

Identifiers

PMID28643901
PMCPMC5655783
OpenAlexW2669264138

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.