IV Iron Treatment of Restless Legs Syndrome

NCT02484768 | Withdrawn Phase 2

• 1 other identifier: P-RLS-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (4)

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

  3 months

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

  from baseline to t = 12 weeks

• Time from baseline to start of RLS medication

  from baseline to t = 6 weeks

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

  from baseline to t = 6 weeks

Other Outcomes (5)

• Type and incidence of adverse drug reactions (ADRs)

  from baseline to t = 18 weeks

• Number of adverse events (AEs) of special interest

  from baseline to t = 18 weeks

• 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

  from baseline to t = 18 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Iron isomaltoside 1000

Group B

PLACEBO COMPARATOR

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

Drug: Sodium Chloride 0.9%

Interventions

Iron isomaltoside 1000 DRUG

Intravenous treatment

Also known as: Monofer

Group A

Sodium Chloride 0.9% DRUG

Intravenous treatment

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• BioStata: collaborator
• Laboratory Corporation of America: collaborator

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

iron isomaltoside 1000; Sodium Chloride

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Richard Allen, Assoc Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: June 30, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06