Status:
TERMINATED
Efficacy of Prednisone In the Treatment of Ocular Myasthenia
Lead Sponsor:
Michael Benatar
Collaborating Sponsors:
University of Miami
University of Rochester
Conditions:
Ocular Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 symptom...
Eligibility Criteria
Inclusion
- Weakness confined to the extra-ocular muscles, eyelid levator and eye closure with an ocular-QMG1 score ≥ 1
- At least one of the following combinations of abnormal diagnostic testing: a) Elevated acetylcholine receptor antibody titers, (b) Abnormal repetitive nerve stimulation (\> 10% decrement following slow repetitive nerve stimulation) of any nerve-muscle pair, (c) Abnormal jitter on single fiber or concentric needle electromyography in any muscle, (d) Positive ice test and brain MRI that demonstrates no central nervous system pathology that mimics ocular myasthenia, or (e) Positive Tensilon test and brain MRI that demonstrate no central nervous system pathology that mimics ocular myasthenia
- Either no prior treatment with pyridostigmine, or participant has persistent ocular symptoms that are functionally limiting or troublesome despite treatment with pyridostigmine.
- Age 18 years or older, male or female
- Capable of providing informed consent and complying with study procedures
- Identifiable primary care physician to assist with management of medical complications that may arise as a consequence of steroid therapy
- Willing to be randomized to a trial of prednisone or placebo if symptoms respond inadequately to pyridostigmine.
Exclusion
- Disease duration (time since symptom onset) \> 5 years
- Treatment with prednisone or other corticosteroids within 90 days of randomization
- Treatment with azathioprine, cyclosporine, mycophenolate mofetil or other immune suppressive medication since onset of MG unless dosages of these medications and/or duration of therapy with these medications are clinically insignificant in the judgment of the PI
- Intravenous immunoglobulin or plasma exchange within 90 days of randomization
- Prior thymectomy or history of thymoma
- Contraindication to steroids (poorly controlled diabetes, glaucoma or hypertension, history of prior steroid intolerance, obesity \[BMI \> 39.9kg/m2\] or a history of osteoporotic fracture)
- Pregnant or lactating
- Renal failure, active thyroid or hepatocellular disease, chronic infection, poorly controlled cardiac disease, unstable psychiatric illness, untreated major depression or any other illness that would, in the opinion of the treating neurologist, make it unsafe for the patient to participate in the trial
- Receipt of another investigational drug within 30 days of Screening
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00995722
Start Date
December 1 2011
End Date
October 1 2013
Last Update
June 2 2017
Active Locations (10)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
University of Miami
Miami, Florida, United States, 33136
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
University at Buffalo, Buffalo General Medical Center
Buffalo, New York, United States, 14203