Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309101
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : June 3, 2009
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: tacrolimus Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Study Start Date : February 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1. tacrolimus Drug: tacrolimus
Other Names:
  • FK506
  • Prograf

Primary Outcome Measures :
  1. Improvement of clinical symptoms [ Time Frame: 28 Weeks ]

Secondary Outcome Measures :
  1. Improvement of daily activity [ Time Frame: 28 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309101

Layout table for location information
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
Layout table for investigator information
Study Chair: Central Contact Astellas Pharma Inc

Layout table for additonal information
Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00309101     History of Changes
Other Study ID Numbers: F506-CL-0602
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009
Keywords provided by Astellas Pharma Inc:
Myasthenia Gravis
Additional relevant MeSH terms:
Layout table for MeSH terms
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action