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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309101

Enrollment

Registered

2006-03-31

Start date

2006-02-28

Completion date

2009-02-28

Last updated

2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis

Keywords

Tacrolimus, Myasthenia Gravis

Brief summary

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

Interventions

DRUGtacrolimus

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement of clinical symptoms	28 Weeks

Secondary

Measure	Time frame
Improvement of daily activity	28 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026