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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00306033 |
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Date of registration:
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21/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
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Scientific title:
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IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00306033 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Vera Bril, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and
worsening weakness
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis
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Intervention(s)
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Drug: Intravenous ImmuneGlobulin
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Primary Outcome(s)
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change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity
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Secondary Outcome(s)
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MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers
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Secondary ID(s)
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03-0712-B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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