Clinical Trial: Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.
Brief Summary:
Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. 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. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and the Guy's Neurological Disability Scale（GNDS） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.
Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd
Current Primary Outcome:
- Medical Research Council（MRC） score [ Time Frame: 49 weeks ]
- maximum grip strength [ Time Frame: 49 weeks ]
- The Guy's Neurological Disability Scale (GDNS) [ Time Frame: 49 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nihon Pharmaceutical Co., Ltd
Dates:
Date Received: April 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: January 17, 2016
Last Verified: October 2014
