Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00306033

Purpose

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.

Condition	Intervention	Phase
Myasthenia Gravis	Drug: Intravenous ImmuneGlobulin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Myasthenia Gravis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity

Secondary Outcome Measures:

MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers

Estimated Enrollment:	50
Study Start Date:	March 2004
Estimated Study Completion Date:	May 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306033

Locations

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

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Vera Bril, MD

University Health Network, Toronto

More Information

No publications provided

Study ID Numbers:	03-0712-B
Study First Received:	March 21, 2006
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00306033 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

myasthenia gravis
immunoglobulin
intravenous immunoglobulin
treatment

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Immunologic Factors
Neuromuscular Diseases
Immunoglobulins, Intravenous

Rho(D) Immune Globulin
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Neuromuscular Diseases
Immunoglobulins, Intravenous
Physiological Effects of Drugs

Nervous System Diseases
Rho(D) Immune Globulin
Neuromuscular Junction Diseases
Myasthenia Gravis
Pharmacologic Actions
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 11, 2009