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

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245777
• Other study ID #: ITiRiP-1
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2010
• Last updated: December 4, 2014
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	Neurocenter of Southern Switzerland, Ospedale Civico	Lugano	Ticino
Switzerland	University Hospital Zurich, Neurology	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Vifor Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Reduction of Periodic Limb Movements in Sleep (PLMS) =50% as measured with actimetry		screening, 7 days, 14 days after iron infusion	Yes
Secondary	Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)		screening, 7 days after iron infusion, 14 days post partum	No
Secondary	Improvement of sleepiness using Epworth Sleepiness Scale (ESS)		screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum	No
Secondary	Improvement of fatigue using Fatigue Severity Scale (FSS)		screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum	No
Secondary	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	Yes
Secondary	Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)		8 weeeks	Yes