Status:
COMPLETED
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Vifor Pharma
Conditions:
Restless Leg Syndrome
Iron Deficiency Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01245777
Start Date
October 1 2009
End Date
December 1 2012
Last Update
December 5 2014
Active Locations (2)
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1
University Hospital Zurich, Neurology
Zurich, Canton of Zurich, Switzerland, 8091
2
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Canton Ticino, Switzerland, 6903