Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial |
- change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity
- 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 |
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 |
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| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Principal Investigator: | Vera Bril, MD | University Health Network, Toronto |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00306033 History of Changes |
| Other Study ID Numbers: | 03-0712-B |
| Study First Received: | March 21, 2006 |
| Last Updated: | March 31, 2006 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
myasthenia gravis immunoglobulin intravenous immunoglobulin treatment |
Additional relevant MeSH terms:
|
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System Nervous System Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Manifestations Neurologic Manifestations Pathologic Processes Signs and Symptoms Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013