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

Primary Purpose

Restless Leg Syndrome, Iron Deficiency Anemia

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
ferric carboxymaltose
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Leg Syndrome focused on measuring RLS, Pregnancy, Iron Deficiency, Anaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Neurocenter of Southern Switzerland, Ospedale Civico
  • University Hospital Zurich, Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ferric carboxymaltose

Arm Description

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

Outcomes

Primary Outcome Measures

Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)

Secondary Outcome Measures

Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
Improvement of fatigue using Fatigue Severity Scale (FSS)
Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
Recording of adverse events
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)

Full Information

First Posted
November 19, 2010
Last Updated
December 4, 2014
Sponsor
University of Zurich
Collaborators
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01245777
Brief Title
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Vifor Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Leg Syndrome, Iron Deficiency Anemia
Keywords
RLS, Pregnancy, Iron Deficiency, Anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ferric carboxymaltose
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ferric carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Time Frame
screening, 7 days, 14 days after iron infusion
Title
Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
Time Frame
screening, 7 days after iron infusion, 14 days post partum
Title
Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
Time Frame
screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Title
Improvement of fatigue using Fatigue Severity Scale (FSS)
Time Frame
screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Title
Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
Description
Recording of adverse events
Time Frame
Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum
Title
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)
Time Frame
8 weeeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Bassetti, Professor
Organizational Affiliation
University Hospital Zurich, Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudio Bassetti, Professor
Organizational Affiliation
Neuroenter of Southern Switzerland, Ospedale Civico, Lugano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurocenter of Southern Switzerland, Ospedale Civico
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
University Hospital Zurich, Neurology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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