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

Completed · Phase 3

Conditions studied: Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT00294658

Run by

University of Alabama at Birmingham

People needed

126

Starts

2006-06-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Data Coordination Center: University of Alabama at Birmingham — Birmingham, Alabama, United States
• Barrow Neurological Institute, Saint Joseph's Hospital and Medical Center, 350 W Thomas Rd — Phoenix, Arizona, United States
• University of Southern California, Doheny Institute, 1450 San Pablo St — Los Angeles, California, United States
• University of California Irvine, 101 The City Drive S, Bldg. 22 C, Route 13 — Orange, California, United States
• California Pacific Medical Center, Castro St & Duboce Ave — San Francisco, California, United States
• University of Florida Jacksonville, Tower I, 8th Floor, 580 W. 8th ST. — Jacksonville, Florida, United States
• University of Miami, 1120 NW 14th Street, Suite 1300 — Miami, Florida, United States
• Emory University, 201 Dowman Dr — Atlanta, Georgia, United States
• Augusta University, 1120 15th St — Augusta, Georgia, United States
• Indiana University, Dept of Neurology, Regenstrief Health Center, 6th floor, 1050 Walnut St, Indiana University Medical Center — Indianapolis, Indiana, United States
• The University of Kansas Medical Center, 3901 Rainbow Blvd. — Kansas City, Kansas, United States
• Brigham and Women's Hospital, 75 Francis Street, 5th Floor Tower — Boston, Massachusetts, United States
• Wayne State University School of Medicine, 4201 St Antoine, 8D UHC — Detroit, Michigan, United States
• William Beaumont Hospital, 3601 W. Thirteen Mile Road, Royal Oak — Royal Oak, Michigan, United States
• University of Minnesota, Department of Neurology, MMC 295, 420 Delaware St. S.E., — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester, 200 First St. SW — Rochester, Minnesota, United States
• St. Louis University, One North Grand St. Louis — St Louis, Missouri, United States
• Robert Wood Johnson University, — New Brunswick, New Jersey, United States
• Mount Sinai Hospital,1 Gustave L. Levy Pl — New York, New York, United States
• University of Rochester, 601 Elmwood Ave — Rochester, New York, United States
• Duke University, 200 Trent Dr — Durham, North Carolina, United States
• Case Western Reserve University, University Hospitals of Cleveland, 1100 Euclid Avenue — Cleveland, Ohio, United States
• The Ohio State University Wexmer Medical Center, Rm 461 Means Hall, The Ohio State University Medical Center,1654 Upham Dr. — Columbus, Ohio, United States
• University of Texas Southwestern Medical Center, 5232 Harry Hines Blvd, — Dallas, Texas, United States
• University of Alabama at Birmingham, Department of Neurology, Sparks Center, Suite 350, 1720 7th Avenue South — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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