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

Don Sanders, MD
Gil Wolfe, MD
Michael McDermott, PhD
Rabi Tawil, MD
Richard Barohn, MD
Ted Burns, MD

Project manager

Alexandra Waltz

Contact information

Email:
(305) 243-3799

Links

http://clinicaltrials.gov/ct2/show/NCT00995722?term=Benatar&rank=1

Presentations / Publications