Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-27 @ 3:05 AM
Study NCT ID:
NCT02484768
Status:
WITHDRAWN
Last Update Posted:
2015-06-30
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Iron Treatment of Restless Legs Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557707', 'term': 'iron isomaltoside 1000'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'as per GCP sponsor/company decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Type and incidence of adverse drug reactions (ADRs)', 'timeFrame': 'from baseline to t = 18 weeks'}, {'measure': 'Number of adverse events (AEs) of special interest', 'timeFrame': 'from baseline to t = 18 weeks', '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)'}, {'measure': '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', 'timeFrame': 'from baseline to t = 18 weeks'}, {'measure': 'Change in vital signs (heart rate and blood pressure) during drug administration', 'timeFrame': 'from baseline to t = 18 weeks'}, {'measure': 'Clinical significant electrocardiogram (ECG) during drug administration', 'timeFrame': 'from baseline to t = 18 weeks'}], 'primaryOutcomes': [{'measure': 'To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score', 'timeFrame': '3 months'}, {'measure': 'Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)', 'timeFrame': 'from baseline to t = 12 weeks'}, {'measure': 'Time from baseline to start of RLS medication', 'timeFrame': 'from baseline to t = 6 weeks'}, {'measure': 'Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6)', 'timeFrame': 'from baseline to t = 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome.\n\nThe 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:\n\n* Group A (42 subjects): 1000 mg iron isomaltoside 1000\n* Group B (21 subjects): Placebo infusion\n\nFurthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.', 'detailedDescription': '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.\n\nFor the individual subject, there will be 4 phases to the study which includes teleconferences (TCs) and 2 visits.\n\nThe treatment and treatment evaluation is the main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Diagnosis of RLS based upon the CH-RLSq and HTDI\n3. IRLS score ≥ 15 at baseline evaluation when off RLS medications\n4. Willingness to participate and signing the informed consent form\n\nExclusion Criteria:\n\n1. S-ferritin \\> 300 ng/mL and/or TfS \\> 50 %\n2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)\n3. Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts\n4. 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\n5. History of active asthma within the last 5 years\n6. Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT \\> 3 times upper limit of normal)\n7. Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)\n8. Rheumatoid arthritis with symptoms or signs of active inflammation\n9. Pregnant or nursing women\n10. Previous IV iron treatment for RLS\n11. IV iron treatment within 1 year prior to screening\n12. Blood transfusion within 4 weeks prior to screening\n13. Planned elective surgery during the study\n14. Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening\n15. 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'}, 'identificationModule': {'nctId': 'NCT02484768', 'briefTitle': 'IV Iron Treatment of Restless Legs Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacosmos A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P-RLS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', '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', 'interventionNames': ['Drug: Iron isomaltoside 1000']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min', 'interventionNames': ['Drug: Sodium Chloride 0.9%']}], 'interventions': [{'name': 'Iron isomaltoside 1000', 'type': 'DRUG', 'otherNames': ['Monofer'], 'description': 'Intravenous treatment', 'armGroupLabels': ['Group A']}, {'name': 'Sodium Chloride 0.9%', 'type': 'DRUG', 'description': 'Intravenous treatment', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard Allen, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacosmos A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioStata', 'class': 'INDUSTRY'}, {'name': 'Laboratory Corporation of America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}