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

Phase 3

Completed

• Conditions: Myasthenia Gravis
• Interventions: Drug: tacrolimus

• Registration Number: NCT00309101
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-03-31
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. tacrolimus	tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Improvement of clinical symptoms	28 Weeks

Secondary Outcome Measures

Name	Time	Method
Improvement of daily activity	28 Weeks