NCT00306033

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Intravenous ImmuneGlobulin

Timeline

• Start date: 2004-03-01
• Completion: 2005-05-01
• First posted: 2006-03-22
• Last updated: 2006-04-03

Locations

1 site across 1 country: Canada