This study will carry out to assess the efficacy of GB-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to assess the safety of GB-0998.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Department of Neurology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, Japan
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
Time frame: 4 weeks
days required for 1 grade improvement of FG
Time frame: 1,2,3,4,6,8,12 weeks
days required for 2 grade improvement of FG
Time frame: 1,2,3,4,6,8,12 weeks
changes in FG
Time frame: 1,2,3,4,6,8,12 weeks
proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline
Time frame: 4weeks
days required for 1 grade improvement of the AG
Time frame: 1,2,3,4,6,8,12 weeks
days required for 2 grade improvement of the AG
Time frame: 1,2,3,4,6,8,12 weeks
changes in AG
Time frame: 1,2,3,4,6,8,12 weeks
changes in grip strength
Time frame: 1,2,4,8,12 weeks
changes in manual muscle testing (MMT)
Time frame: 1,2,4,8,12 weeks
changes in activity of daily living (ADL)
Time frame: 1,2,4,8,12 weeks
changes in motor nerve conduction velocity
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Time frame: 4,12 weeks
changes in FG on rescue treatment
Time frame: 1,2,3,4,6,8,12 weeks