Clinical Research Programs

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A Trial of Mycophenolate Mofetil and Prednisone in Myasthenia Gravis

(THIS TRIAL IS CLOSED TO NEW ENROLLEES)

Principal Investigator: James F. Howard, Jr., M.D., Department of Neurology, University of North Carolina, Chapel Hill, NC 27599-7025

Supported by grants from the Aspreva Pharmaceuticals

A multicenter study to assess the benefit of mycophenolate mofetil (MM) (CellCept) as an add-on therapy in patients with antibody-positive myasthenia gravis (MG) who have not adequately responded to prednisone therapy. This study began in November, 2004. Although preliminary studies and individual case reports have suggested that MM helps patients with MG, this will be the first prospective, placebo-controlled study designed to conclusively demonstrate its effectiveness as a steroid sparing agent in this condition. The study will be carried out at more than 45 academic centers throughout the world, and will be completed in Spring 2007. Each patient will take blinded medication (MM or placebo) along with a tapering of their prednisone dose. To be included, patients must be age 18 or over, cannot have previously taken immunosuppressive medications for MG (azathioprine, cyclosporine, cyclophosphamide, methotrexate), must not have had thymectomy within the previous 12 months, and must not have any disqualifying diseases.

There will be no cost to the patients for study medications, clinic visits or blood tests during the study. Patients will be responsible for transportation costs to and from the study site.

Qualifying patients who are interested in participating may get contact information for the closest center from:

Wendy Roberston, Study Coordinator
3114 Bioinformatics Bldg, Department of Neurology, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7025.

Phone: (919) 966-5522 Fax: (919) 966.2922

Email: robertsonw@neurology.unc.edu

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Have you been diagnosed with MG for less than a year?

Principal Investigator: James F. Howard, Jr., M.D., Department of Neurology, University of North Carolina at Chapel Hill

Patient volunteers with Myasthenia Gravis diagnosed less than 1 year are needed to study how the trigger cells for MG change over time. In order to participate, you will be asked to give a blood sample every 2 or 3 months. There is no cost to participate.

Patients who are interested in participating or obtaining further information should have their physicians contact Dr. James F. Howard, Jr. at UNC-CH (919) 966-5522 and ask for information on the "Lymphocyte Study".

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A Trial of Mycophenolate Mofetil in Myasthenia Gravis

(THIS TRIAL IS CLOSED TO NEW ENROLLEES)

Principal Investigator: Donald B. Sanders, M.D., Box 3403, Duke University Medical Center, Durham, NC 27710

Supported by grants from the Orphan Products Development Program of the US FDA, and Roche Pharmaceuticals Co.

A multicenter study to assess the benefit of mycophenolate mofetil (MM) (CellCept) with low-dose prednisone as the initial immunosuppressive medications in patients with antibody-positive myasthenia gravis (MG) is scheduled to begin in September, 2002. Although preliminary studies and individual case reports have suggested that MM helps patients with MG, this will be the first prospective, placebo-controlled study designed to conclusively demonstrate its effectiveness in this condition. The study will be carried out at eight academic centers throughout the US, and will be completed in Spring 2005. Each patient will take blinded medication (MM or placebo) along with low-dose prednisone for 3 months, and will have the option of receiving MM for an additional 6 months. To be included, patients must be age 18 or over, cannot have previously taken immunosuppressive medications for MG (prednisone, azathioprine, cyclosporine, cyclophosphamide, methotrexate), must not have had thymectomy within the previous 12 months, and must not have any disqualifying diseases.

There will be no cost to the patients for study medications, clinic visits or blood tests during the study. Patients will be responsible for transportation costs to and from the study site.

Qualifying patients who are interested in participating may get contact information for the closest center from:

Bernadette Lipscomb, R.N., Box 3403, Duke University Medical Center, Durham, NC 27710.

Phone: (919)- 681-5176 Fax: (919) 660-3853

Email: Lipsc002@mc.duke.edu

Return to the Carolinas Chapter of the Myasthenia Gravis Foundation Homepage

These pages authored by:

James F. Howard, Jr., M.D.
Professor of Neurology
The University of North Carolina at Chapel Hill