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

Myasthenia Gravis Clinical Trial

Official title:

FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309088
• Other study ID #: F506-CL-0601
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: August 22, 2014
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myasthenia Gravis

Intervention

Drug:
• tacrolimus
oral
• placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]		6 Months	No
Secondary	Total amount of steroid therapy (mg)		6 Months	No
Secondary	QMG score;MG-ADL		6 Months	No
Secondary	Success rate of achievement to the targeted steroid dose		6 Months	No

External Links

•   Link to Results on JAPIC - enter 140547 in the JapicCTI-RNo. field