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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Oral

Other names: FK506, Prograf

Primary outcomes

Improvement of clinical symptoms

Time frame: 28 Weeks

Secondary outcomes

Improvement of daily activity

Time frame: 28 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Mar 31, 2006
Registry last updated: Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed