Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

This study has been completed.
Vifor Inc.
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: November 19, 2010
Last updated: December 4, 2014
Last verified: December 2014

In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population. During pregnancy iron tablets are the only available safe medication but their efficacy is rather poor. It is the aim of this study to examine the efficacy, practicability and safety of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.

20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.

  • Trial with medicinal product

Condition Intervention Phase
Restless Leg Syndrome
Iron Deficiency Anemia
Drug: ferric carboxymaltose
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study of the Efficacy, Practicability and Safety of Intravenous Iron Supplementation Therapy in Moderate to Severe Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS) [ Time Frame: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry [ Time Frame: screening, 7 days, 14 days after iron infusion ] [ Designated as safety issue: Yes ]
  • Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI) [ Time Frame: screening, 7 days after iron infusion, 14 days post partum ] [ Designated as safety issue: No ]
  • Improvement of sleepiness using Epworth Sleepiness Scale (ESS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ] [ Designated as safety issue: No ]
  • Improvement of fatigue using Fatigue Severity Scale (FSS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ] [ Designated as safety issue: No ]
  • Safety of ferric carboxymaltose during pregnancy in the 3rd trimester [ Time Frame: Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum ] [ Designated as safety issue: Yes ]
    Recording of adverse events

  • Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery) [ Time Frame: 8 weeeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ferric carboxymaltose
Hb> 11 g/dl and Ferritin < 35 (controlled by CRP): 500mg to correct iron deficiency Hb ≥ 10 and < 11g/dl; Ferritin < 35 (controlled by CRP): 700 mg Hb ≥9 and < 10 g/dl; Ferritin < 35 (controlled by CRP): 800 mg Hb < 9g/dl; Ferritin < 35 (controlled by CRP): 900 mg
Drug: ferric carboxymaltose
20 women with Restless Legs Syndrome (RLS) and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses.
Other Name: Ferinject


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Pregnant women, singleton pregnancy, in the 3rd trimester
  2. Iron Deficiency (Anaemia) defined as Serum Ferritin < 35ug/l with or without Hb < 11g/dl.
  3. Fulfilling the 4 criteria of the International Restless Legs Study Group (IRLSS)

    • Uncomfortable and unpleasant sensations in the legs
    • An urge to move the legs due to this discomfort and worsening of the symptoms when resting
    • The unpleasant sensations are being relieved by movement such as walking or stretching
    • Worsening of the symptoms in the evening or night
  4. RLS score > 20 (defined as modest to severe RLS symptoms) or RLS symptoms = 3 times per week
  5. Patients = 18 years
  6. Signed informed consent provided

Exclusion criteria: Criteria

  1. Age < 18 years
  2. Multiple pregnancy
  3. Depression, psychiatric disease
  4. Severe internal underlying disease, that causes fatigue and sleepiness and thus may confound the outcome measures
  5. Abuse of alcohol, coffee or drugs
  6. Medication (antipsychotics, antihistaminics, tricyclic or SSRI/SNRI antidepressants, L-Dopa, antidopaminergic medication, medium to strong opioids, antiepileptic medication).
  7. RLS not due to iron deficiency: RLS secondary to other central nervous system disease or injury. Such disorders included peripheral neuropathy, neurodegenerative disorders and multiple sclerosis
  8. RLS secondary to chronic kidney disease
  9. Relevant chronic pain syndrome of the extremities other than RLS
  10. Known proneness to allergic reactions
  11. Known hypersensitivity to Ferric carboxymaltose
  12. Relevant disorders of iron metabolism of other aetiology than iron deficiency (e.g. hemochromatosis, hemosiderosis)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01245777

Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Ticino, Switzerland, 6903
University Hospital Zurich, Neurology
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Vifor Inc.
Principal Investigator: Claudio Bassetti, Professor University Hospital Zurich, Neurology
Principal Investigator: Claudio Bassetti, Professor Neuroenter of Southern Switzerland, Ospedale Civico, Lugano
  More Information

No publications provided

Responsible Party: University of Zurich Identifier: NCT01245777     History of Changes
Other Study ID Numbers: ITiRiP-1
Study First Received: November 19, 2010
Last Updated: December 4, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Iron Deficiency

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Psychomotor Agitation
Restless Legs Syndrome
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Mental Disorders
Metabolic Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
Ferric Compounds
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 07, 2015