Restless Leg Syndrome | Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
Restless Leg Syndrome research study
What is the primary objective of this study?
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
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Restless Leg Syndrome
Iron Deficiency Anemia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ferric carboxymaltose20 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ferric carboxymaltoseHb> 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
Start Date: October 2009
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
Secondary Outcome: Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Study sponsors, principal investigator, and references
Principal Investigator: Claudio Bassetti, Professor
Lead Sponsor: University of Zurich
Collaborator: Vifor Inc.