Trial record 32 of 50 for:    Neuromuscular Manifestations | "myasthenia gravis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306033
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : April 3, 2006
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: Intravenous ImmuneGlobulin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial
Study Start Date : March 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity

Secondary Outcome Measures :
  1. MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306033

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Vera Bril, MD University Health Network, Toronto Identifier: NCT00306033     History of Changes
Other Study ID Numbers: 03-0712-B
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: May 2005

Keywords provided by University Health Network, Toronto:
myasthenia gravis
intravenous immunoglobulin

Additional relevant MeSH terms:
Myasthenia Gravis
Neuromuscular Manifestations
Neurologic Manifestations
Neuromuscular Junction Diseases
Neuromuscular Diseases
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs