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A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325571
First Posted: March 30, 2011
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

Condition Intervention Phase
Myasthenia Gravis Drug: Tacrolimus capsule Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity [ Time Frame: Baseline and at 24 weeks ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 16 weeks ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 20 weeks ]

Secondary Outcome Measures:
  • Changes in Osserman classification [ Time Frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks ]
  • Changes in myasthenia gravis activity of daily living scale [ Time Frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks ]

Enrollment: 83
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tacrolimus group Drug: Tacrolimus capsule
oral
Other Names:
  • Prograf
  • FK506
Placebo Comparator: placebo group Drug: Placebo
oral

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed as myasthenia gravis (MG) by clinical diagnosis
  • QMG scores ≥7 at the time of enrollment
  • basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion Criteria:

  • receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
  • QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
  • abnormal hepatic functions
  • uncontrolled diabetes patients
  • hyperkalemia patients
  • immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
  • patients who are allergic to Tacrolimus or macrolide antibiotics
  • receiving other immuno-inhibitors within 12 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325571


Locations
China
Beijing, China
Guangdong, China
Jiangsu, China
Jilin, China
Shandong, China
Shanghai, China
Sichuan, China
Wuhan, China
Zhejiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma China, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01325571     History of Changes
Other Study ID Numbers: F506-CL-0611
First Submitted: March 16, 2011
First Posted: March 30, 2011
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
prograf
immunosuppressant

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action