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

• ClinicalTrials.gov Identifier: NCT01245777
• Recruitment Status: Completed
• First Posted: November 22, 2010
• Last Update Posted: December 5, 2014
• Sponsor: University of Zurich
• Collaborator: Vifor Pharma
• Information provided by (Responsible Party): University of Zurich

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

Condition or disease	Intervention/treatment	Phase
Restless Leg Syndrome; Iron Deficiency Anemia	Drug: ferric carboxymaltose	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: October 2009
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Locations

Switzerland

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Ticino, Switzerland, 6903

University Hospital Zurich, Neurology

Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Vifor Pharma

Investigators

• Principal Investigator: Claudio Bassetti, Professor; University Hospital Zurich, Neurology
• Principal Investigator: Claudio Bassetti, Professor; Neuroenter of Southern Switzerland, Ospedale Civico, Lugano

More Information

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01245777
• Other Study ID Numbers: ITiRiP-1
• First Posted: November 22, 2010
• Last Update Posted: December 5, 2014
• Last Verified: December 2014

Keywords provided by University of Zurich:

RLS; Pregnancy; Iron Deficiency; Anaemia

Additional relevant MeSH terms:

Psychomotor Agitation; Restless Legs Syndrome; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Syndrome; Disease; Pathologic Processes; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Anemia, Hypochromic; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders