Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Prednisolone; Prednisone

Criteria

Inclusion Criteria:

• Male and female MG patients age greater than 18 and less than 65 years

• Onset of generalized MG within the last 5 years

• Positive serum anti-acetylcholine receptor binding antibodies (muscle acetylcholine receptors, AchRAb =/> 1.00 nmol/L. AchRAb levels of 0.50-0.99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium testing.)

• MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone

Exclusion Criteria:

• Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids

• Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month

• Immunosuppressive therapy other than corticosteroids in the preceding year

• Medically unfit for thymectomy

• Chest CT evidence of thymoma.

• Pregnancy or lactation; contraindications to the use of corticosteroids, unless postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded.

• A serious concurrent medical, neurological or psychiatric condition that would interfere with thymectomy or subsequent clinical assessments

• Current alternate day dose of prednisone > than 1.5 mg/kg or 100 mg or the equivalent daily doses (> 0.75 mg/kg or 50 mg).

• Participation in another experimental clinical trial

• History of alcohol or drug abuse within the 2 years prior to randomization.