Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluate the Functional Grade(FG) and Arm Grade(AG) et al. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Nihon Pharmaceutical Co., Ltd
Osaka, Japan
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
Time frame: Baseline,4weeks
days required for 1 grade improvement of the Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Hughes functional grading scale(FG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
Time frame: Baseline,4weeks
days required for 1 grade improvement of the Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
days required for 2 grade improvement of the Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in Arm Grade(AG)
Time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
changes in manual muscle testing(MMT)
Time frame: Baseline,1,2,3,4,8,12 weeks
changes in grip strength
Time frame: Baseline,1,2,3,4,8,12 weeks
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changes in activity of daily living(ADL)
Time frame: Baseline,1,2,3,4,8,12 weeks
changes in electrophysiological findings
Time frame: Baseline,4,12 weeks