IV Iron Treatment of Restless Legs Syndrome

• Status: Withdrawn
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome.

The study is a randomised, comparative, double-blind study with a 3 months extension. Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following treat-ment groups:

• Group A (42 subjects): 1000 mg iron isomaltoside 1000

• Group B (21 subjects): Placebo infusion

Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Collaborators: BioStata; Laboratory Corporation of America
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Diagnosis of RLS based upon the CH-RLSq and HTDI

3. IRLS score ≥ 15 at baseline evaluation when off RLS medications

4. Willingness to participate and signing the informed consent form

Exclusion Criteria:

1. S-ferritin > 300 ng/mL and/or TfS > 50 %

2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)

3. Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts

4. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing

5. History of active asthma within the last 5 years

6. Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT > 3 times upper limit of normal)

7. Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)

8. Rheumatoid arthritis with symptoms or signs of active inflammation

9. Pregnant or nursing women

10. Previous IV iron treatment for RLS

11. IV iron treatment within 1 year prior to screening

12. Blood transfusion within 4 weeks prior to screening

13. Planned elective surgery during the study

14. Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening

15. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. history of multiple allergies, a malignancy, uncon-trolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes melli-tus