Clinical Trial: 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.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Ther
Brief Summary:
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.
Detailed Summary:
Sponsor: Nihon Pharmaceutical Co., Ltd
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nihon Pharmaceutical Co., Ltd
Dates:
Date Received: April 26, 2013
Date Started: May 2013
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017
