Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myasthenia Gravis
Intervention: Intravenous ImmuneGlobulin (Drug)
Phase: Phase 3
Sponsored by: University Health Network, Toronto
Official(s) and/or principal investigator(s):
Vera Bril, MD, Principal Investigator, Affiliation: University Health Network, Toronto
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
Official title: IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity
Secondary outcome: MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers
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.
Minimum age: 18 Years.
Maximum age: N/A.
- age > or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and
- 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.
Locations and Contacts
University Health Network, Toronto, Ontario M5G 2N2, Canada
Starting date: March 2004
Last updated: March 31, 2006