Myasthenia Graves Research Group

 

MG Research

Efficacy Of Prednisone In The Treatment Of Ocular Myasthenia (EPITOME)

Principal Investigator Michael Benatar, MD, PhD
Site-PI
Summary This is a randomized controlled trial of adjustable dose prednisone in patients with ocular myasthenia gravis. Ocular myasthenia patients whose symptoms have not responded adequately to treatment with pyridostigmine (mestinon) are eligible to participate. Our goals are to investigate the safety and efficacy of prednisone, to identify the optimal dose of prednisone for treating patients with ocular myasthenia and to begin to learn something about whether treatment with prednisone reduces the risk of progression to generalized disease.
Eligibility criteria
  • Ocular myasthenia within 2 years of diagnosis
  • Confirmatory test (e.g. acetylcholine receptor antibodies, repetitive nerve stimulation or single fiber electromyography)
  • Age ≥ 18
  • Inadequate or no prior treatment with cholinesterase inhibitors
  • No prednisone or other steroids within 90 days
  • No prior treatment with immune suppressive therapy
  • No IVIg or plasma exchange within 90 days
  • No thymoma
Funding agency Food & Drug Administration
Collaborators Richard Barohn, MD
Vera Bril, MD
Ted Burns, MD
Michael K Hehir, MD
Vern Juel, MD
Hans Katzberg, MD
Michael McDermott, PhD
Srikanth Muppidi, MD
Richard Nowak, MD, MS
Don Sanders, MD
Nicholas Silvestri, MD
Rabi Tawil, MD
Gil Wolfe, MD
Project manager
Contact information Sara-Claude Michon
Email:
Phone: (305) 243-6481
Links http://clinicaltrials.gov/ct2/show/NCT00995722?term=Benatar&rank=1
Presentations / Publications
  • Benatar M, Sanders DB, Wolfe GI, McDermott MP, Tawil R. Design of the efficacy of prednisone in the treatment of ocular myasthenia (EPITOME) trial. Ann N Y Acad Sci. 2012;1275:17-22.