Clinical trial NCT01245777: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Restless Leg Syndrome
Iron Deficiency Anemia
Keywords: RLS
Pregnancy
Iron Deficiency
Anaemia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2010-11-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
timeFrame: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion
Secondary outcomes:
measure: Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
timeFrame: screening, 7 days, 14 days after iron infusion
measure: Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
timeFrame: screening, 7 days after iron infusion, 14 days post partum
measure: Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
timeFrame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
measure: Improvement of fatigue using Fatigue Severity Scale (FSS)
timeFrame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
measure: Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
timeFrame: Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum
measure: Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)
timeFrame: 8 weeeks
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland, Ospedale Civico
state: Ticino
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Neurology
Study officials:
affiliation: University Hospital Zurich, Neurology
name: Claudio Bassetti, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuroenter of Southern Switzerland, Ospedale Civico, Lugano
name: Claudio Bassetti, Professor
role: PRINCIPAL_INVESTIGATOR
References: