A study to assess the effects of a single administration of ferric carboxymaltose compared with placebo in improving the outcomes of iron deficient non-anaemic patients with restless legs syndrome

A Randomised, Assessor- and Patient-blind, Multicentre, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Outcomes in Iron Deficient Non-anaemic Patients with Restless Legs Syndrome - Ferric carboxymaltose in non-anaemic iron deficient patients with restless legs

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000574-30-DE

Enrollment

110

Registered

2013-07-17

Start date

2013-09-23

Completion date

Unknown

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-anaemic iron deficient patients with restless legs syndrome MedDRA version: 18.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Ferinject Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with RLS 2. Patients with moderate to severe intensity of symptoms (IRLS total score =15) 3. Female or male patients 18 years of age or over 4. Patients must weigh =50 kg 5. Patients with normal haemoglobin levels, defined as =11.5 g/dL (females) or =12.5 g/dL (males) 6. Patients with serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: 1. History or presence of severe psychiatric disorder with the exception of RLS-related mild to moderate depressive symptoms 2. Patients with current augmentation of RLS 3. Patients who were treated for RLS with the following within 4 weeks of baseline: - Medication approved for RLS used in doses higher than as per current prescribing information (Summary of Product Characteristics). - Any combination treatment for RLS. - Medication not approved to treat RLS. 4. History of severe systemic diseases or clinically relevant hepatic dysfunction. 5. Acute or chronic infection, clinically relevant active inflammatory disease, at screening. 6. Known relevant cardiac dysfunction and/or arrhythmias 7. Known history or presence of moderate or severe pain disorders 8. Haemoglobinopathy or haemochromatosis or other iron storage disorders. 9. Use of erythropoietin stimulating agent within 3 months of screening

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of FCM versus placebo in the improvement of symptom severity of restless legs syndrome (RLS) as measured by the International Restless Legs Scale (IRLS) rating after 4 weeks;Secondary Objective: 1. To demonstrate the efficacy of FCM versus placebo in the improvement of symptom severity of RLS as measured by the IRLS rating after 12 weeks. 2. To demonstrate the efficacy of FCM versus placebo according to time to the need for additional non-FCM RLS treatment due to lack or loss of efficacy. ;Primary end point(s): Change in the IRLS total score (gold standard for efficacy evaluation in RLS) between baseline and Week 4 (Day 29).;Timepoint(s) of evaluation of this end point: Week 4	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of FCM versus placebo in the improvement of symptom severity of restless legs syndrome (RLS) as measured by the International Restless Legs Scale (IRLS) rating after 4 weeks;Secondary Objective: 1. To demonstrate the efficacy of FCM versus placebo in the improvement of symptom severity of RLS as measured by the IRLS rating after 12 weeks. 2. To demonstrate the efficacy of FCM versus placebo according to time to the need for additional non-FCM RLS treatment due to lack or loss of efficacy. ;Primary end point(s): Change in the IRLS total score (gold standard for efficacy evaluation in RLS) between baseline and Week 4 (Day 29).;Timepoint(s) of evaluation of this end point: Week 4

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in the IRLS total score (gold standard for efficacy evaluation in RLS) between baseline and Week 12 (Day 85). 2. Time to the need for additional non-FCM RLS treatment due to lack or loss of efficacy between Day 1 and Week 12 (Day 85) (time-to-event analysis). 3. Change between baseline and Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) in the severity of RLS as measured by the 6 items of the RLS-6 scales. 4. Change between baseline and Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) in CGI evaluation (Item 1). 5. Analysis of the CGI ratings (Items 2 and 3) at Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) and of the PGI-I efficacy rating at Weeks 4 (Day 29) and 12 (Day 85). 6. Proportion of patients with at least 50% improvement from baseline in the IRLS total score at Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) (Responder A). 7. Proportion of patients with an improvement by at least 6 points in the IRLS from baseline at any time during the treatment period (Responder B). 8. Change in disease-specific QoL-RLS between baseline and Weeks 4 (Day 29) and 12 (Day 85).;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 12 3. Weeks 4, 8, 12 4. Weeks 4, 8, 12 5. Weeks 1, 4, 8, 12 6. Weeks 1, 4, 8, 12 7. Week 12 8. Weeks 4, 12	—

Measure

Time frame

Secondary end point(s): 1. Change in the IRLS total score (gold standard for efficacy evaluation in RLS) between baseline and Week 12 (Day 85). 2. Time to the need for additional non-FCM RLS treatment due to lack or loss of efficacy between Day 1 and Week 12 (Day 85) (time-to-event analysis). 3. Change between baseline and Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) in the severity of RLS as measured by the 6 items of the RLS-6 scales. 4. Change between baseline and Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) in CGI evaluation (Item 1). 5. Analysis of the CGI ratings (Items 2 and 3) at Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) and of the PGI-I efficacy rating at Weeks 4 (Day 29) and 12 (Day 85). 6. Proportion of patients with at least 50% improvement from baseline in the IRLS total score at Weeks 1 (Day 7), 4 (Day 29), 8 (Day 57) and 12 (Day 85) (Responder A). 7. Proportion of patients with an improvement by at least 6 points in the IRLS from baseline at any time during the treatment period (Responder B). 8. Change in disease-specific QoL-RLS between baseline and Weeks 4 (Day 29) and 12 (Day 85).;Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 12 3. Weeks 4, 8, 12 4. Weeks 4, 8, 12 5. Weeks 1, 4, 8, 12 6. Weeks 1, 4, 8, 12 7. Week 12 8. Weeks 4, 12

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Countries

Finland, Germany, Switzerland

Contacts

Public ContactMedical Information

Vifor (International) Inc.

medinfo@viforpharma.com41588518222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026