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

NCT ID: NCT01245777

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-12-31

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

Conditions

Restless Leg Syndrome; Iron Deficiency Anemia

Keywords

RLS; Pregnancy; Iron Deficiency; Anaemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ferric carboxymaltose

Intervention Type: DRUG

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.

Interventions

ferric carboxymaltose

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.

Intervention Type: DRUG

Other Intervention Names

Ferinject

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Bassetti, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Neurology

Claudio Bassetti, Professor

Role: PRINCIPAL_INVESTIGATOR

Neuroenter of Southern Switzerland, Ospedale Civico, Lugano

Locations

University Hospital Zurich, Neurology

Zurich, Canton of Zurich, Switzerland

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Canton Ticino, Switzerland

Countries

Switzerland

Other Identifiers

ITiRiP-1

Identifier Type: -

Identifier Source: org_study_id