Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
|ClinicalTrials.gov Identifier: NCT01827072|
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : January 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multifocal Motor Neuropathy||Drug: NPB-01||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Other Name: immunoglobulin
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827072
|Nihon Pharmaceutical Co., Ltd|