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IV Iron Treatment of Restless Legs Syndrome

Primary Purpose

Restless Legs Syndrome

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Iron isomaltoside 1000

Sodium Chloride 0.9%

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of RLS based upon the CH-RLSq and HTDI
IRLS score ≥ 15 at baseline evaluation when off RLS medications
Willingness to participate and signing the informed consent form

Exclusion Criteria:

S-ferritin > 300 ng/mL and/or TfS > 50 %
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts
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
History of active asthma within the last 5 years
Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT > 3 times upper limit of normal)
Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnant or nursing women
Previous IV iron treatment for RLS
IV iron treatment within 1 year prior to screening
Blood transfusion within 4 weeks prior to screening
Planned elective surgery during the study
Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score

Secondary Outcome Measures

Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score

Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)

Time from baseline to start of RLS medication

Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6)

Full Information

NCT ID

NCT02484768

First Posted

March 30, 2015

Last Updated

June 25, 2015

Sponsor

Pharmacosmos A/S

Collaborators

BioStata, Laboratory Corporation of America

1. Study Identification

Unique Protocol Identification Number

NCT02484768

Brief Title

IV Iron Treatment of Restless Legs Syndrome

Official Title

A Phase II, Six-week, Randomised, Comparative, Double-blind Study of Intravenous Iron Isomaltoside 1000 Versus Placebo in Subjects With Restless Leg Syndrome With a 3 Month Extension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Withdrawn

Why Stopped

as per GCP sponsor/company decision

Study Start Date

January 2015 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

Collaborators

BioStata, Laboratory Corporation of America

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Iron isomaltoside 1000

Other Intervention Name(s)

Monofer

Intervention Description

Intravenous treatment

Intervention Type

Drug

Intervention Name(s)

Sodium Chloride 0.9%

Intervention Description

Intravenous treatment

Primary Outcome Measure Information:

Title

To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score

Time Frame

3 months

Title

Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)

Time Frame

from baseline to t = 12 weeks

Title

Time from baseline to start of RLS medication

Time Frame

from baseline to t = 6 weeks

Title

Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6)

Time Frame

from baseline to t = 6 weeks

Other Pre-specified Outcome Measures:

Title

Type and incidence of adverse drug reactions (ADRs)

Time Frame

from baseline to t = 18 weeks

Title

Number of adverse events (AEs) of special interest

Description

(i.e. hypersensitivity symptoms such as: urticaria, oedema, bronchospasm, hypotension, cardiorespiratory arrest, syn-cope, unresponsiveness, or loss of consciousness at pre-specified time points in relation to administration of study drug)

Time Frame

from baseline to t = 18 weeks

Title

Change in haematology parameters, s-sodium, s-potassium, s-calcium, s-phosphate, s-urea, s-creatinine, s-albumin, s-bilirubin, aspartate aminotransferase (ASAT), and ala-nine aminotransferase (ALAT) from baseline to week 6 and month 3

Time Frame

from baseline to t = 18 weeks

Title

Change in vital signs (heart rate and blood pressure) during drug administration

Time Frame

from baseline to t = 18 weeks

Title

Clinical significant electrocardiogram (ECG) during drug administration

Time Frame

from baseline to t = 18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Diagnosis of RLS based upon the CH-RLSq and HTDI IRLS score ≥ 15 at baseline evaluation when off RLS medications Willingness to participate and signing the informed consent form Exclusion Criteria: S-ferritin > 300 ng/mL and/or TfS > 50 % Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis) Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts 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 History of active asthma within the last 5 years Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT > 3 times upper limit of normal) Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP) Rheumatoid arthritis with symptoms or signs of active inflammation Pregnant or nursing women Previous IV iron treatment for RLS IV iron treatment within 1 year prior to screening Blood transfusion within 4 weeks prior to screening Planned elective surgery during the study Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Allen, Assoc Prof

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

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IV Iron Treatment of Restless Legs Syndrome

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