Efficacy of Prednisone In the Treatment of Ocular Myasthenia

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ocular Myasthenia Gravis

In brief

The purpose of this study is to evaluate the efficacy and tolerability of prednisone in patients diagnosed with ocular myasthenia. Funding Source - FDA OOPD

Key facts

Study ID

NCT00995722

Run by

Michael Benatar

People needed

11

Starts

2011-12-01

Expected to finish

2013-10-01

Last updated by the study team

2017-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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