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Sponsors and Collaborators: |
University of Kansas Food and Drug Administration (FDA) |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00814138 |
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 |
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Myasthenia Gravis |
Drug: Methotrexate Other: Placebo |
Phase II |
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 |
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 |
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1: Active Comparator
Methotrexate
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Drug: Methotrexate
10 mg weekly
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2: Placebo Comparator
Placebo
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Other: Placebo
Weekly
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard Barohn, MD | 913-588-6094 | rbarohn@kumc.edu |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Richard Barohn, MD | University of Kansas |
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 |
myasthenia gravis |
Folic Acid Autoimmune Diseases Neuromuscular Diseases Myasthenia gravis |
Methotrexate Myasthenia Gravis Autoimmune Diseases of the Nervous System |
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 |