- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285350
Mycophenolate Mofetil in Myasthenia Gravis
A Trial of Mycophenolate Mofetil in Myasthenia Gravis
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
Acquired generalized MG diagnosed by one of the Principal Investigators based on:
- Examination by site PI showing myasthenic weakness that is not limited to the ocular or peri-ocular muscles.
- Elevated acetylcholine receptor antibodies.
- Positive edrophonium chloride test or abnormal neuromuscular transmission demonstrated by single fiber EMG or repetitive nerve stimulation.
- Aged at least 18.
- Able to give informed consent.
- Taking a constant dose of Mestinon for at least 2 weeks.
- Symptom severity that would, in the judgment of the site investigator, justify initiation of immunosuppressive treatment.
- Able and willing to comply with study requirements.
Exclusion criteria
- Thymoma now or in the past.
- Plasma exchange or IVIG treatment within 90 days of randomization.
Treatment with azathioprine, cyclosporine, mycophenolate mofetil, or other immunosuppressive medication since onset of MG. Treatment with prednisone or other corticosteroids within the previous 90 days.
• Exception: patients may have taken doses of these immunosuppressant medications that are judged by the Principal Investigator to have been clinically insignificant, i.e. unlikely to produce improvement in MG.
- Women of childbearing potential who are pregnant, breast-feeding or not practicing effective contraception.
- Renal failure, active thyroid or hepatocellular disease, chronic infection, poorly controlled cardiac disease, or any other illness, including psychiatric disease, that would, in the opinion of the treating physician, make it unsafe for the patient to participate or would interfere with the interpretation of study results.
- Weakness affecting only ocular or peri-ocular muscles (Myasthenia Gravis Foundation of America Class I).
- Severe weakness predominantly affecting oropharyngeal, respiratory muscles or both (MGFA Class IVB).
- Crisis or impending crisis (defined as FVC <10ml/Kg or bulbar weakness severe enough to compromise airway protection.)
- Hemoglobin <10mg/dl; WBC <3,500.
- History of non-compliance with treatment and office visits.
- Thymectomy within 12 months before randomization.
- Concurrent medical condition that would pose an unacceptable risk from immunosuppression, including a positive skin test for tuberculosis (PPD), unless the patient has previously received appropriate treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
QMGS
|
Secondary Outcome Measures
Outcome Measure |
---|
Multiple
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Donald B Sanders, MD, Duke University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Muscle Weakness
- Myasthenia Gravis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Mycophenolic Acid
Other Study ID Numbers
- 2154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myasthenia Gravis
-
Assiut UniversityRecruitingNervous System Diseases | Autoimmune Diseases of the Nervous System | Thymoma | Myasthenia Gravis | Neuromuscular Junction Diseases | Myasthenia Gravis, Generalized | Myasthenia Gravis Crisis | Myasthenia Gravis, Ocular | Myasthenia Gravis, Juvenile Form | Thymus Hyperplasia | Myasthenia Gravis With Exacerbation... and other conditionsEgypt
-
Universiti Putra MalaysiaEnrolling by invitationExperimental MyastheniaChina
-
Universiti Putra MalaysiaCompletedExperimental MyastheniaChina
-
Alexion Pharmaceuticals, Inc.CompletedMyasthenia Gravis | Myasthenia Gravis, Generalized | Myasthenia Gravis, Juvenile FormUnited States, Japan, Netherlands
-
Catalyst Pharmaceuticals, Inc.CompletedMyasthenia Gravis, GeneralizedUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedMyasthenia Gravis, Thymectomy
-
argenxNot yet recruiting
-
Myasthenia Gravis Rare Disease NetworkRecruitingMyasthenia Gravis | MuSK Myasthenia Gravis | MuSK MGUnited States
-
Kyverna TherapeuticsNot yet recruitingGeneralized Myasthenia Gravis | Myasthenia Gravis
-
UCB Biopharma SRLNot yet recruitingGeneralized Myasthenia Gravis
Clinical Trials on mycophenolate mofetil
-
University of GiessenNovartis; Hoffmann-La Roche; Astellas Pharma Inc; Heidelberg UniversityCompletedPolyomavirus InfectionsGermany
-
Novartis PharmaceuticalsCompletedRenal TransplantationUnited States
-
Nanjing University School of MedicineCompletedVasculitis | Anti-Neutrophil Cytoplasmic AntibodyChina
-
Nanjing University School of MedicineCompletedNephritis | Henoch-Schoenlein PurpuraChina
-
Children's Hospital of Fudan UniversityShanghai Children's Hospital; Shanghai Children's Medical Center; Xinhua Hospital...WithdrawnSteroid-Dependent Nephrotic Syndrome | Frequently Relapsing Nephrotic SyndromeChina
-
Teva Branded Pharmaceutical Products R&D, Inc.ParexelTerminatedStable Renal Transplant Recipients
-
Panacea Biotec LtdCompletedHealthy VolunteersIndia
-
Fred Hutchinson Cancer CenterUniversity of WashingtonCompleted
-
Panacea Biotec LtdCompletedHealthy VolunteersIndia
-
Samsung Medical CenterUnknown