Efficacy of Methotrexate in Myasthenia Gravis

Completed · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

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

Key facts

Study ID

NCT00814138

Run by

University of Kansas Medical Center

People needed

50

Starts

2009-04-01

Expected to finish

2014-01-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States
• University of California, San Francisco — Fresno, California, United States
• University of California-Irvine — Irvine, California, United States
• Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• University of Florida, Health Science Center Jacksonville — Jacksonville, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospitals — Boston, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Penn State College of Medicine, The Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The Nerve and Muscle Center of Texas — Houston, Texas, United States
• University Health Sciences Center, San Antonio — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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