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Methotrexate in Myasthenia Gravis
This study is not yet open for participant recruitment.
Verified by University of Kansas, December 2008
Sponsors and Collaborators: University of Kansas
Food and Drug Administration (FDA)
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00814138
  Purpose

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.


Condition Intervention Phase
Myasthenia Gravis
Drug: Methotrexate
Other: Placebo
Phase II

MedlinePlus related topics: Myasthenia Gravis
Drug Information available for: Methotrexate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Phase II Trial of Methotrexate in Myasthenia Gravis

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Total prednisone dose [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative Myasthenia Gravis score [ Time Frame: baseline, monthly for 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Methotrexate
Drug: Methotrexate
10 mg weekly
2: Placebo Comparator
Placebo
Other: Placebo
Weekly

  Eligibility

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

Inclusion Criteria:

  • 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. Additionally, the patient must meet the steroid-dependency definition as outlined in the protocol.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814138

Contacts
Contact: Richard Barohn, MD 913-588-6094 rbarohn@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Richard Barohn, MD University of Kansas
  More Information

Responsible Party: University of Kansas Medical Center ( Richard Barohn MD )
Study ID Numbers: 11552
Study First Received: December 23, 2008
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00814138  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas:
myasthenia gravis

Study placed in the following topic categories:
Folic Acid
Autoimmune Diseases
Neuromuscular Diseases
Myasthenia gravis
Methotrexate
Myasthenia Gravis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Neuromuscular Junction Diseases
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009