Status:
COMPLETED
Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed Description
Myasthenia gravis (MG) is an autoimmune disease involving the thymus in which 85 percent of patients have antibodies to muscle acetylcholine receptors (AchR-Ab) that interfere with neuromuscular trans...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00294658
Start Date
June 1 2006
End Date
December 1 2015
Last Update
May 23 2017
Active Locations (70)
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1
University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South
Birmingham, Alabama, United States, 35233
2
Data Coordination Center: University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Barrow Neurological Institute, Saint Joseph's Hospital and Medical Center, 350 W Thomas Rd
Phoenix, Arizona, United States, 85016
4
University of Southern California, Doheny Institute, 1450 San Pablo St
Los Angeles, California, United States, 90033