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

Phase 4

Completed

• Conditions: Restless Leg Syndrome; Iron Deficiency Anemia
• Interventions: Drug: ferric carboxymaltose

• Registration Number: NCT01245777
• Lead Sponsor: University of Zurich

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 available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ferric carboxymaltose	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Recording of adverse events
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)	8 weeeks

Trial Locations

Locations (2)

University Hospital Zurich, Neurology; 🇨🇭 Zurich, Switzerland

Neurocenter of Southern Switzerland, Ospedale Civico; 🇨🇭 Lugano, Ticino, Switzerland