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

NCT00997412 | Unknown

• 1 other identifier: CERL080ATW07T
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)

  One year after treatment

Secondary Outcomes (2)

• Osserman clinical classification

  One year after treatment

• Myasthenia gravis (MG) score

  One year after treatment

Study Arms (2)

MA

EXPERIMENTAL

MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily

Drug: Mycophenolic acid

AZA

ACTIVE COMPARATOR

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

Drug: AZA

Interventions

Mycophenolic acid DRUG

180 mg/tablet, 4 tablets twice daily

MA

AZA DRUG

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

AZA

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age between 20-70 (including 20 and 70 years old).
• Osserman II and III Myasthenia Gravis.
• Positive serum anti-acetylcholine receptor antibodies.
• Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment.
• Without immunosuppressive therapy other than steroid.

You may not qualify if:

• Ocular MG or minimal clinical syndrome that would not require the therapy of steroids.
• Negative serum anti-acetylcholine receptor antibodies.
• Use immunosuppressants other than steroids in the preceding year.
• Previous use other investigational medication within 3 months or current participate other clinical study.
• Poor renal function: serum creatinine \> 3.0 mg/dl or estimated creatinine clearance \< 30 ml/min
• Females who are pregnancy or breast-feeding.
• Recent history, within 5 years, of malignancy
• Unwilling or unable to participate the necessary continuous visits and examinations.

Sponsors & Collaborators

• Qualitix Clinical Research Co., Ltd.: lead

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Jiann-Horng Yeh, M.D.

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 19, 2009

Record last verified: 2009-10