FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.

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Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

oral

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

Interventions

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tacrolimus

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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Prograf FK506

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are well-controlled by the treatment with prednisone
* Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain

Exclusion Criteria

* Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
* Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
* Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
* Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
* Pancreatitis or diabetes
* Serum creatinine≦1.5mg/dL

Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No