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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 December 2012
• Main ID: NCT00294658
• Date of registration: 21/02/2006
• Primary sponsor: Gary Cutter, PhD
• Public title: Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
• Scientific title: A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone
• Date of first enrolment: June 2006
• Target sample size: 150
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00294658
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Gary Cutter, PhD
• Affiliation: University of Alabama at Birmingham School of Public Health, Department of Biostatistics

• Name: Gil Wolfe, MD
• Affiliation: University of Texas Southwestern Medical Center

Key inclusion & exclusion 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 (AchR Ab =/> 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 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: prednisone

Procedure: thymectomy

Primary Outcome(s)

Comparison of the prednisone treatment alone to thymectomy (ETTX) plus prednisone treatment, based on the clinical response to therapy measured over the 3 year trial period by the Area Under the Quantitative Myasthenia Gravis Weakness Score [Time Frame: 3 years]

Testing the difference of total prednisone used over the 3 year trial period measured by pill count from blister packs (Area Under the prednisone Dose Time Curve, AUDTC) conditional on the results of comparing AUQMG. [Time Frame: 3 years]

Secondary ID(s)

1U01NS042685-01A2

2UO1NS042685-06

CRC

R01NS050733

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)