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

NCT01245777 | Completed Phase 4 DMC

• 1 other identifier: ITiRiP-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Restless Leg Syndrome; Iron Deficiency Anemia

Keywords

RLS; Pregnancy; Iron Deficiency; Anaemia

Outcome Measures

Primary Outcomes (1)

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

  3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion

Secondary Outcomes (6)

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

  screening, 7 days, 14 days after iron infusion

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

  screening, 7 days after iron infusion, 14 days post partum

• Improvement of sleepiness using Epworth Sleepiness Scale (ESS)

  screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum

• Improvement of fatigue using Fatigue Severity Scale (FSS)

  screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum

• Safety of ferric carboxymaltose during pregnancy in the 3rd trimester

  Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum

Study Arms (1)

ferric carboxymaltose

EXPERIMENTAL

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

Interventions

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.

Also known as: Ferinject

ferric carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Vifor Pharma: collaborator

Study Sites (2)

University Hospital Zurich, Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Canton Ticino, 6903, Switzerland

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Anemia, Iron-Deficiency; Iron Deficiencies; Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Claudio Bassetti, Professor

  University Hospital Zurich, Neurology

  PRINCIPAL INVESTIGATOR

• Claudio Bassetti, Professor

  Neuroenter of Southern Switzerland, Ospedale Civico, Lugano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

CH (2)