Clinical Trial: Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

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.


Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd

Current Primary Outcome: proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks. [ Time Frame: Baseline,4weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Nihon Pharmaceutical Co., Ltd

Dates:
Date Received: August 12, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017