Back to resultsAn Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Primary Purpose
Myasthenia Gravis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring Tacrolimus, Myasthenia Gravis
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed as myasthenia gravis Those whose MG symptoms are not controlled by the treatment with prednisone Exclusion Criteria: Those who had undergone thymectomy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1. tacrolimus
Arm Description
Outcomes
Primary Outcome Measures
Improvement of clinical symptoms
Secondary Outcome Measures
Improvement of daily activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00309101
Brief Title
An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Official Title
FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
Tacrolimus, Myasthenia Gravis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. tacrolimus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
FK506, Prograf
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Improvement of clinical symptoms
Time Frame
28 Weeks
Secondary Outcome Measure Information:
Title
Improvement of daily activity
Time Frame
28 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed as myasthenia gravis
Those whose MG symptoms are not controlled by the treatment with prednisone
Exclusion Criteria:
Those who had undergone thymectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushu region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
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