Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy 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 Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.|
- proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. [ Time Frame: 28weeks ]
- proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. [ Time Frame: 52weeks ]
- INCAT score [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
- ISS [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
- maximum grip strength [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
- Medical Research Council（MRC） sum score [ Time Frame: 1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks ]
- the amplitude of the compound muscle action potential of the most severely affected motor nerve [ Time Frame: 1,4,28,52weeks ]
|Study Start Date:||April 2013|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Other Name: Intravenous immunoglobulin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824251
|Nihon Pharmaceutical Co., Ltd|