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Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis

Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myasthenia Gravis

Intervention: Intravenous ImmuneGlobulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Vera Bril, MD, Principal Investigator, Affiliation: University Health Network, Toronto

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.

Clinical Details

Official title: IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University Health Network, Toronto, Ontario M5G 2N2, Canada
Additional Information

Starting date: March 2004
Ending date: May 2005
Last updated: March 31, 2006

Page last updated: June 20, 2008

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