Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306033
Status:
COMPLETED
Last Update Posted:
2006-04-03
First Post:
2006-03-21
Brief Title:
Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Students 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None