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

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ClinicalTrials.gov Identifier: NCT01325571
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: Tacrolimus capsule Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: tacrolimus group Drug: Tacrolimus capsule
oral
Other Names:
  • Prograf
  • FK506

Placebo Comparator: placebo group Drug: Placebo
oral




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

Secondary Outcome Measures :
  1. Changes in Osserman classification [ Time Frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01325571     History of Changes
Other Study ID Numbers: F506-CL-0611
First Posted: March 30, 2011    Key Record Dates
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