Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy - Full Text View

Purpose

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:	Allocation: Randomized 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:

MedlinePlus related topics: Anemia Iron Restless Legs

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (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

Eligibility

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

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245777

Contacts

Contact: Claudio Bassetti, Professor	+41 (0)44 255 11 11	Claudio.Bassetti@usz.ch
Contact: Juliane Schneider, MD		juliane.schneider@usz.ch

Locations

Switzerland
Neurocenter of Southern Switzerland, Ospedale Civico	Recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Claudio Bassetti, Professor +41 811 6501 Claudio.Bassetti@eoc.ch
Contact: Pamela Agazzi, MD pamela.agazzi@eoc.ch
Principal Investigator: Claudio Bassetti, Professor
Sub-Investigator: Pamela Agazzi, MD
Sub-Investigator: Monika Raimondi, MD
Sub-Investigator: Iraida Pisarenco, MD
Sub-Investigator: Mauro Manconi, MD
University Hospital Zurich, Neurology	Recruiting
Zurich, Switzerland, 8091
Contact: Claudio Bassetti, Professor claudio.bassetti@usz.ch
Contact: Juliane Schneider, MD juliane.schneider@usz.ch
Principal Investigator: Juliane Schneider, MD

Sponsors and Collaborators

University of Zurich

Vifor Inc.

Investigators

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:	Bassetti Claudio, Professor Dr. med., University Hospital Zurich, NOS Neurologische Klinik
ClinicalTrials.gov Identifier:	NCT01245777 History of Changes
Other Study ID Numbers:	ITiRiP-1
Study First Received:	November 19, 2010
Last Updated:	June 10, 2011
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

RLS
Pregnancy
Iron Deficiency
Anaemia

Additional relevant MeSH terms:

Anemia
Restless Legs Syndrome
Deficiency Diseases
Psychomotor Agitation
Anemia, Iron-Deficiency
Hematologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Malnutrition
Nutrition Disorders
Dyskinesias

Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics

ClinicalTrials.gov processed this record on June 17, 2013