IV Iron Treatment of Restless Legs Syndrome

NCT ID: NCT02484768

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-02-28

Brief 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.

Detailed Description

RLS is a disorder of sensation with a prevalence of around 2-5 % of the population. RLS is extremely responsive to dopaminergic agents, but a second issue is that iron deficiency states may precipitate RLS in as much as 25-30 % of subjects with iron deficiency. RLS appears to be related to deficits in brain iron content and metabolism. Magnetic resonance imaging (MRI) images demonstrate a decrease in substantia nigra and red nucleus iron content. The severity of this decrease in brain iron content is correlated with the severity of symptoms. A number of patients are quite resistant to dietary iron repletion but do resolve symptoms with high doses of intravenous (IV) iron.

For the individual subject, there will be 4 phases to the study which includes teleconferences (TCs) and 2 visits.

The treatment and treatment evaluation is the main study.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Infusion of 1000 mg iron isomaltoside 1000 at baseline. The infusion is diluted in 100 mL 0.9 % sodium chloride and given over approximately 15 min

Group Type: EXPERIMENTAL

Iron isomaltoside 1000

Intervention Type: DRUG

Intravenous treatment

Group B

Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9%

Intervention Type: DRUG

Intravenous treatment

Interventions

Iron isomaltoside 1000

Intravenous treatment

Intervention Type: DRUG

Sodium Chloride 0.9%

Intravenous treatment

Intervention Type: DRUG

Other Intervention Names

Monofer

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioStata

INDUSTRY

Sponsor Role: collaborator

Laboratory Corporation of America

INDUSTRY

Sponsor Role: collaborator

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Allen, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA

Other Identifiers

P-RLS-01

Identifier Type: -

Identifier Source: org_study_id