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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00309088
First received: March 29, 2006
Last updated: July 9, 2008
Last verified: July 2008
History of Changes

March 29, 2006
July 9, 2008
April 2006
June 2008   (final data collection date for primary outcome measure)
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.] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00309088 on ClinicalTrials.gov Archive Site
  • Total amount of steroid therapy (mg) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • QMG score;MG-ADL [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Success rate of achievement to the targeted steroid dose [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
FK506 Phase 3 Study: a Study for Steroid Non-Resistant Myasthenia Gravis (MG) Patients
FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myasthenia Gravis
  • Drug: tacrolimus
    oral
    Other Names:
    • Prograf
    • FK506
  • Drug: placebo
    oral
  • Experimental: 1
    Intervention: Drug: tacrolimus
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. Epub 2011 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
16 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00309088
F506-CL-0601
Not Provided
Director, Astellas Pharma, Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP