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

Myasthenia Gravis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325571
• Other study ID #: F506-CL-0611
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2011
• Last updated: March 8, 2016
• Start date: March 2011
• Est. completion date: May 2014

Study information

• Verified date: March 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis

Intervention

Drug:
• Tacrolimus capsule
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity		Baseline and at 24 weeks	No
Primary	Change from baseline in QMG score for disease severity		Baseline and at 4 weeks	No
Primary	Change from baseline in QMG score for disease severity		Baseline and at 8 weeks	No
Primary	Change from baseline in QMG score for disease severity		Baseline and at 12 weeks	No
Primary	Change from baseline in QMG score for disease severity		Baseline and at 16 weeks	No
Primary	Change from baseline in QMG score for disease severity		Baseline and at 20 weeks	No
Secondary	Changes in Osserman classification		Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks	No
Secondary	Changes in myasthenia gravis activity of daily living scale		Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks	No

External Links

•   Link to results on Astellas Clinical Study Results Web site
•   Link to Results on JAPIC - enter 150713 in the JapicCTI-RNo. field