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

Study Overview
=================
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

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

Conditions
-----------------
Restless Leg Syndrome, Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: ferric carboxymaltose


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ferric carboxymaltose<br>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<br>* 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.<br>* Other names: Ferinject;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Recording of adverse events | Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum | 
| Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery) |  | 8 weeeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS, Pregnancy, Iron Deficiency, Anaemia