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Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
This study is currently recruiting participants.
Verified by Benesis Corporation, August 2007
Sponsored by: Benesis Corporation
Information provided by: Benesis Corporation
ClinicalTrials.gov Identifier: NCT00515450
  Purpose

This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998


Condition Intervention Phase
Generalized Myasthenia Gravis
Biological: GB-0998 (Intravenous immunoglobulin)
Procedure: Plasmapheresis
Phase III

MedlinePlus related topics: Myasthenia Gravis
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Further study details as provided by Benesis Corporation:

Primary Outcome Measures:
  • Changes in QMG score [ Time Frame: at 4 weeks ]

Secondary Outcome Measures:
  • Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels [ Time Frame: from beginning of the treatment through 4th week ]

Estimated Enrollment: 46
Study Start Date: July 2007
Estimated Study Completion Date: May 2009
Arms Assigned Interventions
1: Experimental Biological: GB-0998 (Intravenous immunoglobulin)
2: Active Comparator Procedure: Plasmapheresis

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as generalized myasthenia gravis
  • Patients who are not controlled by current therapy and need plasmapheresis therapy
  • Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent
  • Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment

Exclusion Criteria:

  • Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment
  • Patients who had undergone thymectomy within 24 weeks prior to enrollment
  • Patients with 3 points item in bulbar symptom of MG-ADL scale
  • Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
  • Patients who have received treatment of malignant tumors
  • Patients who have the anamnesis of shock or hypersensitivity to this drug
  • Patients who have been diagnosed as hereditary fructose intolerance
  • Patients who have the anamnesis of cerebral infarction or symptom of these diseases
  • Patients who have been diagnosed as IgA deficiency in their past history
  • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant
  • Patients who were administered other investigational drug within 12 weeks before consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515450

Contacts
Contact: Yoshiyuki Fukushima +81-6-6227-5295 5802155@cc.m-pharma.co.jp

Locations
Japan
Nagasaki University Recruiting
Nagasaki, Japan, 852-8501
Principal Investigator: Masakatsu Motomura, Assist. Prof            
Sponsors and Collaborators
Benesis Corporation
Investigators
Study Chair: Masaharu Takamori, Director Neurological Center Kanazawa-Nishi Hospital
  More Information

Study ID Numbers: 0998-B1
Study First Received: August 10, 2007
Last Updated: August 19, 2007
ClinicalTrials.gov Identifier: NCT00515450  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Benesis Corporation:
Myasthenia Gravis

Study placed in the following topic categories:
Antibodies
Autoimmune Diseases
Neuromuscular Diseases
Immunoglobulins, Intravenous
Myasthenia gravis
Rho(D) Immune Globulin
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Junction Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009