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 syndrome; MedDRA version: 18.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-000574-30-FI
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-19
• Last Update Posted: 8 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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 <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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified