Myasthenia Gravis
Conditions
Keywords
myasthenia gravis, immunoglobulin, intravenous immunoglobulin, treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntravenous ImmuneGlobulin
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity | — |
Secondary
| Measure | Time frame |
|---|---|
| MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers | — |
Countries
Canada
Outcome results
None listed