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Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

NCT00997412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-10-19

No results posted yet for this study

Summary

This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.

Conditions

Interventions

DRUG

Mycophenolic acid

180 mg/tablet, 4 tablets twice daily

DRUG

AZA

1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily

Sponsors & Collaborators

  • Qualitix Clinical Research Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jiann-Horng Yeh, M.D. · Shin Kong Wu Ho-Su Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997412 on ClinicalTrials.gov