Overview

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.