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

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ClinicalTrials.gov Identifier: NCT00309088
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: tacrolimus Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
Study Start Date : April 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus
oral
Other Names:
  • Prograf
  • FK506
Placebo Comparator: 2 Drug: placebo
oral



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Total amount of steroid therapy (mg) [ Time Frame: 6 Months ]
  2. QMG score;MG-ADL [ Time Frame: 6 Months ]
  3. Success rate of achievement to the targeted steroid dose [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309088


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
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00309088     History of Changes
Other Study ID Numbers: F506-CL-0601
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Myasthenia Gravis

Additional relevant MeSH terms:
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action