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

Tracking Information

• First Submitted Date: November 19, 2010
• First Posted Date: November 22, 2010
• Last Update Posted Date: December 5, 2014
• Study Start Date: October 2009
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 7, 2011): 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 ]

Original Primary Outcome Measures (submitted: November 19, 2010)

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

Current Secondary Outcome Measures (submitted: June 10, 2011)

• Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry [ Time Frame: screening, 7 days, 14 days after iron infusion ]
• Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI) [ Time Frame: screening, 7 days after iron infusion, 14 days post partum ]
• Improvement of sleepiness using Epworth Sleepiness Scale (ESS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ]
• Improvement of fatigue using Fatigue Severity Scale (FSS) [ Time Frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum ]
• 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
• Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery) [ Time Frame: 8 weeeks ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Restless Leg Syndrome
• Iron Deficiency Anemia

Intervention

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

Study Arms

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

Intervention: Drug: ferric carboxymaltose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2014): 15
• Original Estimated Enrollment (submitted: November 19, 2010): 20
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01245777
• Other Study ID Numbers: ITiRiP-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Zurich
• Original Responsible Party: Bassetti Claudio, Professor Dr. med., University Hospital Zurich, NOS Neurologische Klinik
• Current Study Sponsor: University of Zurich
• Original Study Sponsor: Same as current
• Collaborators: Vifor Pharma

Investigators

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

• PRS Account: University of Zurich
• Verification Date: December 2014