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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.
ClinicalTrials.gov Identifier: NCT00309101
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : June 3, 2009
Sponsor:
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

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
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1. tacrolimus Drug: tacrolimus
Oral
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

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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov 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:
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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action