Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Benesis Corporation
ClinicalTrials.gov Identifier:
NCT00515450
First received: August 10, 2007
Last updated: July 29, 2010
Last verified: July 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: GB-0998 (Intravenous immunoglobulin)
Other Name: Venoglobulin-IH
Active Comparator: 2 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

Locations
Japan
Nagasaki University
Nagasaki, Japan, 852-8501
Sponsors and Collaborators
Benesis Corporation
Investigators
Study Chair: Masaharu Takamori, Director Neurological Center Kanazawa-Nishi Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00515450     History of Changes
Other Study ID Numbers: 0998-B1
Study First Received: August 10, 2007
Last Updated: July 29, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Benesis Corporation:
Myasthenia Gravis

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013