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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245777
First Posted: November 22, 2010
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vifor Inc.
Information provided by (Responsible Party):
University of Zurich
November 19, 2010
November 22, 2010
December 5, 2014
October 2009
December 2012   (Final data collection date for primary outcome measure)
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 ]
  • Primary endpoint: = 50% reduction of RLS symptoms as measured by IRLSS
  • Primary endpoint: = 50% reduction of Restless Legs Syndrome(RLS) symptoms as measured by IRLSS
Complete list of historical versions of study NCT01245777 on ClinicalTrials.gov Archive Site
  • Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry [ Time Frame: screening, 7 days, 14 days after iron infusion ]
  • Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI) [ Time Frame: screening, 7 days after iron infusion, 14 days post partum ]
  • Improvement of sleepiness using Epworth Sleepiness Scale (ESS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ]
  • Improvement of fatigue using Fatigue Severity Scale (FSS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ]
  • 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 ]
    Recording of adverse events
  • Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery) [ Time Frame: 8 weeeks ]
Not Provided
Not Provided
Not Provided
 
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
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

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
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Restless Leg Syndrome
  • Iron Deficiency Anemia
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
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
Intervention: Drug: ferric carboxymaltose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2012
December 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01245777
ITiRiP-1
Yes
Not Provided
Not Provided
University of Zurich
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
University of Zurich
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP