Spots Global Cancer Trial Database for Efficacy of Prednisone In the Treatment of Ocular Myasthenia
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Trial Identification
Brief Title: Efficacy of Prednisone In the Treatment of Ocular Myasthenia
Official Title: Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study
Study ID: NCT00995722
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and tolerability of prednisone in patients diagnosed with ocular myasthenia. Funding Source - FDA OOPD
Detailed Description: The purpose of this study is to learn two things about prednisone in patients with ocular myasthenia. The first thing we aim to learn is 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 thing we aim to learn is whether we can find a dose of prednisone that is well tolerated and safe. The overall goal is to find out whether a dose of prednisone that is safe and well tolerated is also effective in improving the symptoms of ocular myasthenia. After completing screening assessments to confirm eligibility, all participants will receive treatment with pyridostigmine. If a participant's symptoms do not resolve within the first month while being treated with pyridostigmine, they will be randomized to receive prednisone or placebo. The amount of study medication a participant receives will depend on how their symptoms respond to the medication and if they experience any side effects. After four months, participants that continue to have symptoms of ocular myasthenia and do not have side effects will receive open label high dose prednisone. Participants that no longer have symptoms will taper their dose of study drug in a double-blind fashion.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale University, New Haven, Connecticut, United States
University of Miami, Miami, Florida, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University at Buffalo, Buffalo General Medical Center, Buffalo, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Vermont, Burlington, Vermont, United States
University of Virginia, Charlottesville, Virginia, United States
University of Alberta Hospital, Edmonton, Alberta, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Contact Details
Name: Michael Benatar, MBChB, DPhil
Affiliation: University of Miami
Role: PRINCIPAL_INVESTIGATOR
Name: Gil Wolfe, MD
Affiliation: State University of New York at Buffalo
Role: STUDY_DIRECTOR
Name: Donald Sanders, MD
Affiliation: Duke University
Role: STUDY_DIRECTOR
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