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IV Iron Treatment of Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT02484768
Recruitment Status : Withdrawn (as per GCP sponsor/company decision)
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborators:
BioStata
Laboratory Corporation of America
Information provided by (Responsible Party):
Pharmacosmos A/S

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.


Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Iron isomaltoside 1000 Drug: Sodium Chloride 0.9% Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Restless Legs

Arm Intervention/treatment
Experimental: 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
Drug: Iron isomaltoside 1000
Intravenous treatment
Other Name: Monofer

Placebo Comparator: Group B
Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min
Drug: Sodium Chloride 0.9%
Intravenous treatment




Primary Outcome Measures :
  1. 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 Measures :
  1. Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score [ Time Frame: 3 months ]
  2. 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 ]
  3. Time from baseline to start of RLS medication [ Time Frame: from baseline to t = 6 weeks ]
  4. 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 Outcome Measures:
  1. Type and incidence of adverse drug reactions (ADRs) [ Time Frame: from baseline to t = 18 weeks ]
  2. Number of adverse events (AEs) of special interest [ Time Frame: from baseline to t = 18 weeks ]
    (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)

  3. 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 ]
  4. Change in vital signs (heart rate and blood pressure) during drug administration [ Time Frame: from baseline to t = 18 weeks ]
  5. Clinical significant electrocardiogram (ECG) during drug administration [ Time Frame: from baseline to t = 18 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484768


Sponsors and Collaborators
Pharmacosmos A/S
BioStata
Laboratory Corporation of America
Investigators
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Principal Investigator: Richard Allen, Assoc Prof Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02484768     History of Changes
Other Study ID Numbers: P-RLS-01
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Iron
Iron isomaltoside 1000
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics