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

June 2, 2009 updated by: Astellas Pharma Inc

FK506 Phase 3 Study: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. tacrolimus
Drug: tacrolimus
Oral
Other Names:
  • Prograf
  • FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of clinical symptoms
Time Frame: 28 Weeks
28 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of daily activity
Time Frame: 28 Weeks
28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F506-CL-0602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe