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Dexpramipexole

Phase II Trial of Methotrexate in Myasthenia Gravis

 

Principal Investigator

Richard Barohn, MD

Site-PI

Michael Benatar, MD, PhD

Summary

The specific aim of this trial is to determine if oral methotrexate is an effective therapy for patients with generalized myasthenia gravis who are dependent on prednisone. Patients with inadequately controlled disease despite treatment with prednisone will be randomized to receive either methotrexate or placebo. The hypothesis is that the addition of methotrexate will improve the manifestation of myasthenia and permit tapering of the prednisone dose.

Eligibility criteria

  • Generalized myasthenia gravis,
  • Elevated acetylcholine receptor antibody titers
  • Prednisone dose of at least 10mg/day (stable dose for at least 30 days)
  • No current or prior (within 60 days) treatment with other immune suppressive therapy including IVIg
  • No thymoma
  • No prior use of methotrexate

Funding agency

Food and Drug Administration

Collaborators

Richard Barohn, MD
Mamatha Pasnoor, MD
Mazen Dimachkie, MD

Project manager

Julie Steele, RN

Contact information

Email:

Links

http://clinicaltrials.gov/ct2/show/NCT00814138?term=barohn&rank=1

Presentations / Publications

 

 
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