Dr. Michael Benatar, Neuromuscular Division Chief and Associate Professor of Neurology at the University of Miami, currently has a research project underway for patients with ocular myasthenia gravis. Below is general information about the study, including contact information if you are interested in finding out whether you are eligible to participate.

Efficacy of Prednisone In the Treatment of Ocular Myasthenia (EPITOME')

What is the purpose of the study?
The purpose of this study is to learn two things about prednisone, a corticosteroid drug, in patients diagnosed with ocular myasthenia. The first aim is to learn whether or not prednisone is effective in improving the symptoms of double vision and drooping eyes that are experienced by patients with ocular myasthenia. The second aim is to learn whether a dose of prednisone that is well tolerated and safe can be determined.

Who can participate?
Ocular myasthenia patients who have not received treatment with pyridostigmine (mestinon), or whose symptoms have not responded adequately to treatment with pyridostigmine (mestinon) are eligible to participate. Additional information about patient eligibility criteria is available.

What is involved?
Study Visits: The study will last approximately 9 months. Participants will complete screening assessments to confirm eligibility and have a Baseline evaluation, and then return for follow-up visits once a month for a total of 9 more visits. They will also receive regular check-in phone calls from the study coordinator throughout the duration of the study.

Treatment: All participants will receive treatment with pyridostigmine (mestinon), which is a drug used to decrease muscle weakness resulting from myasthenia gravis. If a participant's symptoms do not resolve within the first month while being treated with mestinon, he or she will be randomly assigned to receive study medication: either prednisone or placebo (sugar pill with no active medicine). All participants who continue to have symptoms of ocular myasthenia after taking the study medication (prednisone or placebo) for 4 months will receive prednisone at the end of the placebo-controlled part of the trial.

HOW TO GET MORE INFORMATION:

Contact Sara-Claude Michon, Research Coordinator for more information about eligibility requirements and participation:

Phone: 305-243-6481
Email: scmichon@med.miami.edu

For additional details about this study, visit www.clinicaltrials.gov and search for trial identifier: NCT00814138