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

Information source: Benesis Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Myasthenia Gravis

Intervention: GB-0998 (Intravenous immunoglobulin) (Biological); Plasmapheresis (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Benesis Corporation

Official(s) and/or principal investigator(s):
Masaharu Takamori, Director, Study Chair, Affiliation: Neurological Center Kanazawa-Nishi Hospital

Overall contact:
Yoshiyuki Fukushima, Phone: +81-6-6227-5295, Email: 5802155@cc.m-pharma.co.jp


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

Clinical Details

Official title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Changes in QMG score

Secondary outcome: Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


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


- Patients who were administered other investigational drug within 12 weeks before


Locations and Contacts

Yoshiyuki Fukushima, Phone: +81-6-6227-5295, Email: 5802155@cc.m-pharma.co.jp

Nagasaki University, Nagasaki 852-8501, Japan; Recruiting
Masakatsu Motomura, Assist. Prof, Principal Investigator
Additional Information

Starting date: July 2007
Ending date: May 2009
Last updated: August 19, 2007

Page last updated: November 03, 2008

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