Neuromyelitis Optica Spectrum Disorder Clinical Trial
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.
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.
n/a
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