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

This study is currently recruiting participants.
Verified October 2011 by Astellas Pharma Inc
Sponsor:
Collaborator:
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01325571
First received: March 16, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in QMG score for disease severity [ Time Frame: Baseline and at 20 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325571

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01325571     History of Changes
Other Study ID Numbers: F506-CL-0611
Study First Received: March 16, 2011
Last Updated: October 10, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
prograf
immunosuppressant

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013