Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-30 @ 4:30 PM
Study NCT ID:
NCT00933868
Status:
COMPLETED
Last Update Posted:
2012-05-25
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015636', 'term': 'Magnesium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-23', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-07-03', 'lastUpdatePostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthel Index', 'timeFrame': 'Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions'}], 'secondaryOutcomes': [{'measure': 'Improvement in muscle strength and function', 'timeFrame': 'Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions'}, {'measure': 'Change in the Mini-mental status examination', 'timeFrame': 'Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions'}, {'measure': 'Change in balance, coordination, range of motion', 'timeFrame': 'Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions'}, {'measure': 'Incidence of adverse events and changes in vital signs', 'timeFrame': 'Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['A stroke that occurred three months to four years ago'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.', 'detailedDescription': 'The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects of either sex above 18 years of age\n2. Documented history of stroke 3 months to four years ago\n3. Subjects may have had two or more strokes\n4. Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body\n5. Must be assessed as a 2 or 3 on the Modified Rankin Scale\n6. Must have a Barthel score at or below 85\n\nExclusion Criteria:\n\n1. Any traumatic brain injury or other brain injury apart from stroke\n2. Renal insufficiency or renal failure\n3. Any medical or physical condition that would interfere with the measurements to be conducted\n4. Any physical therapy in a facility outside their home within three days of screening'}, 'identificationModule': {'nctId': 'NCT00933868', 'briefTitle': 'Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relox Medical, LLC'}, 'officialTitle': 'Comparison of Magnesium Chloride Infusions Versus Placebo Administered Concomitantly With 100% Oxygen Given to Patients Who Have Residual Muscle Weakness From a Stroke That Occurred Three Months to Four Years Ago', 'orgStudyIdInfo': {'id': 'RM-R001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium infusion in patients breathing 100% oxygen', 'description': 'Patients will be given six infusions over three weeks. Each infusion will last between 4 and 10 minutes. They will then return to clinic in 1,2 and 3 months for the same tests (but no infusions will be given).', 'interventionNames': ['Drug: Magnesium Chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion', 'description': 'The patients will receive six placebo infusions after which they will return to clinic at one, two and three months. At the conclusion of the trial those patients who received placebo may elect to receive the active treatment in another (open label) trial that will begin shortly after this one concludes.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Magnesium Chloride', 'type': 'DRUG', 'description': 'An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen', 'armGroupLabels': ['Magnesium infusion in patients breathing 100% oxygen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent', 'armGroupLabels': ['Placebo infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49512', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Born Preventive Healthcare Clinic, PC', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10901', 'city': 'Suffern', 'state': 'New York', 'country': 'United States', 'facility': 'Schachter Center for Complementary Medicine', 'geoPoint': {'lat': 41.11482, 'lon': -74.14959}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Comprehensive Heart Care Inc.', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Bert Spilker, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President, Bert Spilker & Associates, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relox Medical, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lead Principal Investigator', 'investigatorFullName': 'Bert Spilker', 'investigatorAffiliation': 'Relox Medical, LLC'}}}}