Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00309101
First received: March 29, 2006
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Myasthenia Gravis
 Drug: tacrolimus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Improvement of clinical symptoms [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of daily activity [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. tacrolimus Drug: tacrolimus
Oral
Other Names:
  • FK506
  • Prograf

  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309101

Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Hokuriku region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00309101     History of Changes
Other Study ID Numbers: F506-CL-0602
Study First Received: March 29, 2006
Last Updated: June 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Myasthenia Gravis

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
 Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013