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
- Conditions
- on-anaemic iron deficient patients with restless legs syndromeMedDRA version: 18.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2013-000574-30-DE
- Lead Sponsor
- Vifor (International) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
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 <75 mcg/L
7. Patients who are naïve to RLS medication, or who will have taken no RLS medication for at least 7 days before baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 77
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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.<br>;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
- Secondary Outcome Measures
Name Time Method