Restless Leg SyndromePhase 4NCT01245777
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
A Phase 4 study testing ferric carboxymaltose in people with Restless Leg Syndrome and Iron Deficiency Anemia, run by University of Zurich at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Restless Leg Syndrome, Iron Deficiency Anemia
- What is being tested?
- ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Oct 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Canton Ticino, 6903
University Hospital Zurich, Neurology
Zurich, Canton of Zurich, 8091
About this study
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
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
- Being tested
- ferric carboxymaltose
- Keywords
- RLS, Pregnancy, Iron Deficiency, Anaemia
- Medical subject headings
- Restless Legs Syndrome, Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric carboxymaltoseDrug
Also called Ferinject
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.
| Study group | Role | What they receive |
|---|---|---|
| ferric carboxymaltose | Experimental | 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 Receives: Drug: ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
Measured: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion
Secondary outcomes (6)
Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Measured: screening, 7 days, 14 days after iron infusion
Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
Measured: screening, 7 days after iron infusion, 14 days post partum
Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
Measured: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Improvement of fatigue using Fatigue Severity Scale (FSS)
Measured: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
Recording of adverse events
Measured: Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)
Measured: 8 weeeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Claudio Bassetti, Professor, Principal investigator, University Hospital Zurich, NeurologyClaudio Bassetti, Professor, Principal investigator, Neuroenter of Southern Switzerland, Ospedale Civico, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245777
- Sponsor's protocol ID
- ITiRiP-1
- Status last verified
- Dec 2014
- First submitted
- 19 Nov 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01245777
- Acronym / sponsor ID
- ITiRiP-1
- Conditions
- Restless Leg Syndrome, Iron Deficiency Anemia
- Keywords
- RLS, Pregnancy, Iron Deficiency, Anaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ferric carboxymaltose | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- RLS score > 20 (defined as modest to severe RLS symptoms) or RLS symptoms = 3 times per week
- Patients = 18 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferric carboxymaltoseAlso: Ferinject20 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. | Drug | ferric carboxymaltose |
Primary outcome
Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
Time frame: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion
6 secondary outcomes
Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
Time frame: screening, 7 days, 14 days after iron infusion
Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
Time frame: screening, 7 days after iron infusion, 14 days post partum
Improvement of sleepiness using Epworth Sleepiness Scale (ESS)
Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Improvement of fatigue using Fatigue Severity Scale (FSS)
Time frame: screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum
Safety of ferric carboxymaltose during pregnancy in the 3rd trimester
Time frame: Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum
Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)
Time frame: 8 weeeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Bassetti, Professor principal investigator
University Hospital Zurich, Neurology
Claudio Bassetti, Professor principal investigator
Neuroenter of Southern Switzerland, Ospedale Civico, Lugano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ferric carboxymaltose in people with Restless Leg Syndrome and Iron Deficiency Anemia, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS) (time frame: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.