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Completed

NCT Number: NCT01245777

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

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Key information

Conditions

Restless Leg Syndrome Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Dyssomnias Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Neurocenter of Southern Switzerland, Ospedale Civico, Lugano, Canton Ticino, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women, singleton pregnancy, in the 3rd trimester
  • Iron Deficiency (Anaemia) defined as Serum Ferritin < 35ug/l with or without Hb < 11g/dl.
  • 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
  • RLS score > 20 (defined as modest to severe RLS symptoms) or RLS symptoms = 3 times per week
  • Patients = 18 years
  • Signed informed consent provided

Exclusion criteria

Criteria

  • Age < 18 years
  • Multiple pregnancy
  • Depression, psychiatric disease
  • Severe internal underlying disease, that causes fatigue and sleepiness and thus may confound the outcome measures
  • Abuse of alcohol, coffee or drugs
  • Medication (antipsychotics, antihistaminics, tricyclic or SSRI/SNRI antidepressants, L-Dopa, antidopaminergic medication, medium to strong opioids, antiepileptic medication).
  • 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
  • RLS secondary to chronic kidney disease
  • Relevant chronic pain syndrome of the extremities other than RLS
  • Known proneness to allergic reactions
  • Known hypersensitivity to Ferric carboxymaltose
  • Relevant disorders of iron metabolism of other aetiology than iron deficiency (e.g. hemochromatosis, hemosiderosis)

Treatment and study plan

ferric carboxymaltose

Drug

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 names: Ferinject

Primary outcomes

  1. 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

Secondary outcomes

  1. Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry

    Time frame: screening, 7 days, 14 days after iron infusion

  2. Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)

    Time frame: screening, 7 days after iron infusion, 14 days post partum

  3. Improvement of sleepiness using Epworth Sleepiness Scale (ESS)

    Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum

  4. Improvement of fatigue using Fatigue Severity Scale (FSS)

    Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum

  5. 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

  6. Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)

    Time frame: 8 weeeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Vifor Pharma

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2010
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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