Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.
|ClinicalTrials.gov Identifier: NCT01845584|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : April 12, 2017
Patients diagnosed with anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive steroid plus therapy （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and spinal cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） and anti-aquaporin 4 antibody 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|
|Neuromyelitis Optica Spectrum Disorder||Drug: NPB-01||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy.|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Other Name: Intravenous immunoglobulin
- Change from Baseline Quantification of nerve and spinal cord impairment （QOSI） at 29 days [ Time Frame: 29 days ]
- Change from Baseline Expanded Disability Status Scale （EDSS）/ Functional Systems （FS） at 29 days [ Time Frame: 29 days ]
- Change from Baseline anti-aquaporin 4 antibody at 29 days [ Time Frame: 29 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845584