An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Myasthenia Gravis Clinical Trial

Official title:

FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309101
• Other study ID #: F506-CL-0602
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: June 2, 2009
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis

Intervention

Drug:
• tacrolimus
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of clinical symptoms		28 Weeks	No
Secondary	Improvement of daily activity		28 Weeks	No