Efficacy of Methotrexate in Myasthenia Gravis
This trial is active, not recruiting.
|Sponsor||University of Kansas|
|Start date||April 2009|
|End date||April 2014|
|Trial size||50 participants|
|Trial identifier||NCT00814138, 11552, FDA OOPD 003538|
Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are prednisone dependent. Patients will be randomized to receive either methotrexate or placebo and those who are entered onto this trial will have symptoms and signs of the disease while on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients will improve the MG manifestations so that the prednisone dose can be reduced and clinical measures of MG severity will improve.
Funding Source - FDA OOPD
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Phoenix Neurological Associates||no longer recruiting|
|Fresno, CA||University of California, San Francisco||no longer recruiting|
|Irvine, CA||University of California-Irvine||no longer recruiting|
|San Francisco, CA||Forbes Norris MDA/ALS Research Center||no longer recruiting|
|Iowa City, IA||University of Iowa Hospitals and Clinics||no longer recruiting|
|Kansas City, KS||University of Kansas Medical Center||no longer recruiting|
|Boston, MA||Massachusetts General Hospitals||no longer recruiting|
|Chapel Hill, NC||University of North Carolina||no longer recruiting|
|Columbus, OH||Ohio State University||no longer recruiting|
|Hershey, PA||Penn State College of Medicine, The Milton S. Hershey Medical Center||no longer recruiting|
|Dallas, TX||University of Texas Southwestern Medical Center||no longer recruiting|
|Houston, TX||The Nerve and Muscle Center of Texas||no longer recruiting|
|San Antonio, TX||University Health Sciences Center, San Antonio||no longer recruiting|
|Charlottesville, VA||University of Virginia||no longer recruiting|
|Toronto, Canada||University of Toronto||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Total prednisone dose
time frame: 9 months
Quantitative Myasthenia Gravis score
time frame: baseline, monthly for 12 months
Male or female participants at least 18 years old.
- Patients must have MGFA MG grades 2, 3, or 4 generalized myasthenia gravis, according to the MGFA classification system
- Elevated acetylcholine receptor antibody (AChR-Ab) titer.
- Patient's signs and symptoms should not be better explained by another disease process.
- Prednisone dose of at least 10 mg/day (or the equivalent in alternate days) and the subject must be on a stable dose of prednisone for 30 days prior to the screening visit.
- A history of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
- Other major chronic or debilitating illnesses within six months prior to study entry.
- Female patients who are premenopausal and are: (a) pregnant on the basis of a serum pregnancy test, (b) breast-feeding, or (c) not using an effective method of double barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) birth control (birth control pills, male condom, female condom, intrauterine device, Norplant, tubal ligation, or other sterilization procedures).
- Altered levels of consciousness, dementia, or abnormal mental status.
- Evidence of thymoma on chest CT or MRI. Such a finding could require immediate thymectomy and would preclude entry into the study.
- Thymectomy in the previous three months.
- Patients who have been medicated with azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, IVIg, or other immunosuppressive drugs within the last 60 days.
- Chest X-ray with evidence of tumor, infection, or interstitial lung disease.
- Clinical history of chronic or recurrent infections.
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
- History of renal or hepatic insufficiency or liver enzymes greater than the upper limit of normal.
- History of bone marrow hypoplasia, leucopenia, thrombocytopenia, significant anemia, clinical or laboratory evidence of immunodeficiency syndromes.
- Forced Vital Capacity (FVC) <50% of predicted.
- MG Grade 1 (ocular only) or 5 (crisis, requiring ventilator).
- Prior use of methotrexate for any condition.
|Official title||Phase II Trial of Methotrexate in Myasthenia Gravis|
|Principal investigator||Richard Barohn, MD|
Call for more information