Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
|ClinicalTrials.gov Identifier: NCT01824251|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : January 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyneuropathy||Drug: NPB-01||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Other Name: Intravenous immunoglobulin
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824251
|Nihon Pharmaceutical Co., Ltd|