Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT00306033
Status:
COMPLETED
Last Update Posted:
2006-04-03
First Post:
2006-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2006-03-31', 'studyFirstSubmitDate': '2006-03-21', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity'}], 'secondaryOutcomes': [{'measure': 'MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers'}]}, 'conditionsModule': {'keywords': ['myasthenia gravis', 'immunoglobulin', 'intravenous immunoglobulin', 'treatment'], 'conditions': ['Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness.', 'detailedDescription': "Patients aged 18 years or older with a diagnosis of myasthenia gravis (MG) and worsening weakness were enrolled in the study after providing informed consent. Fifty-two patients were recruited to the study, but one withdrew consent prior to starting so that 51 patients were recruited. Baseline clinical assessments using the Quantitative MG Score for Disease Severity (QMGS) were repeated at 2 and 4 weeks after treatment with IVIG or saline infusion. The Post-Intervention Status was assessed at 2 and 4 weeks after treatment. The treatment was randomized and double-masked. Electrophysiological and immunological tests were done at baseline and after 2 weeks. Baseline characteristics were compared by the Student's t test for continuous variables or Chi-square test for categorical variables. An analysis of covariance was performed for the primary outcome measure, the change in QMGS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness\n\nExclusion Criteria:\n\n* age \\<18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00306033', 'briefTitle': 'Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '03-0712-B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous ImmuneGlobulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vera Bril, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}}}}