NCT00309101

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

March 29, 2006

Last Update Submit

June 2, 2009

Conditions

Myasthenia Gravis

Keywords

TacrolimusMyasthenia Gravis

Outcome Measures

Primary Outcomes (1)

  • Improvement of clinical symptoms

    28 Weeks

Secondary Outcomes (1)

  • Improvement of daily activity

    28 Weeks

Study Arms (1)

1. tacrolimus

EXPERIMENTAL
Drug: tacrolimus

Interventions

tacrolimusDRUG

Oral

Also known as: FK506, Prograf
1. tacrolimus

Eligibility Criteria

Age16 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinically diagnosed as myasthenia gravis
  • Those whose MG symptoms are not controlled by the treatment with prednisone

You may not qualify if:

  • Those who had undergone thymectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Hokuriku Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 31, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

JP(9)