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Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515450
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : July 30, 2010
Information provided by:
Benesis Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Biological: GB-0998 (Intravenous immunoglobulin) Procedure: Plasmapheresis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Study Start Date : July 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Biological: GB-0998 (Intravenous immunoglobulin)
Other Name: Venoglobulin-IH

Active Comparator: 2 Procedure: Plasmapheresis

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00515450

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Nagasaki University
Nagasaki, Japan, 852-8501
Sponsors and Collaborators
Benesis Corporation
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Study Chair: Masaharu Takamori, Director Neurological Center Kanazawa-Nishi Hospital
Layout table for additonal information Identifier: NCT00515450    
Other Study ID Numbers: 0998-B1
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010
Keywords provided by Benesis Corporation:
Myasthenia Gravis
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs