- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00309088
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
August 22, 2014 updated by: Astellas Pharma Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
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
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 64 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
oral
|
EXPERIMENTAL: 1
|
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total amount of steroid therapy (mg)
Time Frame: 6 Months
|
6 Months
|
QMG score;MG-ADL
Time Frame: 6 Months
|
6 Months
|
Success rate of achievement to the targeted steroid dose
Time Frame: 6 Months
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (ACTUAL)
June 1, 2008
Study Completion (ACTUAL)
June 1, 2008
Study Registration Dates
First Submitted
March 29, 2006
First Submitted That Met QC Criteria
March 29, 2006
First Posted (ESTIMATE)
March 31, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 22, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Muscle Weakness
- Myasthenia Gravis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Calcineurin Inhibitors
- Tacrolimus
Other Study ID Numbers
- F506-CL-0601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myasthenia Gravis
-
Assiut UniversityRecruitingNervous System Diseases | Autoimmune Diseases of the Nervous System | Thymoma | Myasthenia Gravis | Neuromuscular Junction Diseases | Myasthenia Gravis, Generalized | Myasthenia Gravis Crisis | Myasthenia Gravis, Ocular | Myasthenia Gravis, Juvenile Form | Thymus Hyperplasia | Myasthenia Gravis With Exacerbation... and other conditionsEgypt
-
Universiti Putra MalaysiaEnrolling by invitationExperimental MyastheniaChina
-
Universiti Putra MalaysiaCompletedExperimental MyastheniaChina
-
Catalyst Pharmaceuticals, Inc.TerminatedMyasthenia Gravis, MuSK | AChR Myasthenia GravisUnited States, Italy
-
Alexion Pharmaceuticals, Inc.CompletedMyasthenia Gravis | Myasthenia Gravis, Generalized | Myasthenia Gravis, Juvenile FormUnited States, Japan, Netherlands
-
COUR Pharmaceutical Development Company, Inc.Not yet recruitingMyasthenia Gravis | Generalized Myasthenia | AChR Myasthenia Gravis | MuSK MGUnited States
-
Catalyst Pharmaceuticals, Inc.CompletedMyasthenia Gravis, GeneralizedUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedMyasthenia Gravis, Thymectomy
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
argenxNot yet recruitingGeneralized Myasthenia Gravis
Clinical Trials on tacrolimus
-
Novartis PharmaceuticalsCompletedLiver Transplant RecipientBelgium, Spain, Germany, Italy, Australia, United States, Netherlands, Ireland, Sweden, Brazil, Colombia, France, Russian Federation, Argentina, Czechia, United Kingdom
-
Novartis PharmaceuticalsCompletedLiver TransplantationUnited States, Belgium, Colombia, Spain, Germany, Italy, Australia, Israel, France, Hungary, Netherlands, Argentina, Canada, Ireland, Sweden, Brazil, United Kingdom, Russian Federation, Czech Republic
-
Astellas Pharma IncAstellas Pharma Korea, Inc.CompletedLiver TransplantationKorea, Republic of
-
Heleen GrootjansChiesi Farmaceutici S.p.A.RecruitingLung Transplant; ComplicationsNetherlands
-
The Methodist Hospital Research InstituteVeloxis PharmaceuticalsWithdrawnAcute Rejection of Renal Transplant | Kidney Disease, End-Stage | Donor Specific Antibodies
-
Taro Pharmaceuticals USACompleted
-
Peking Union Medical College HospitalUnknown
-
Technical University of MunichCompleted
-
Limerick BioPharmaCompleted
-
University of British ColumbiaPaladin Labs Inc.RecruitingLiver Transplantation | Neurotoxicity | Tremor | Tacrolimus | ImmunosuppressionCanada