Clinical Trial: Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
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
Detailed Summary:
Sponsor: Benesis Corporation
Current Primary Outcome: Changes in QMG score [ Time Frame: at 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels [ Time Frame: from beginning of the treatment through 4th week ]
Original Secondary Outcome: Same as current
Information By: Benesis Corporation
Dates:
Date Received: August 10, 2007
Date Started: July 2007
Date Completion:
Last Updated: July 29, 2010
Last Verified: July 2010