Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial|
- change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity
- MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||May 2005|
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.
|University Health Network|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Vera Bril, MD||University Health Network, Toronto|