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.

Inclusion criteria

• Patients who become positive for anti-aquaporin 4 antibody or have becomed.
• Patients who have developed myelitis.
• Patients who run beyond greater than 30 days at least from last time in relapse.
• Patients who new neurological symptom or worsening neurological symptom or flared neurological symptom have sustained 24 hours at least not associated fever or infection.
• Patients who have an acute exacerbation at informed consent.
• Patients who need steroid plus therapy（1g/day for five consecutive days）.
• Patients who can start steroid plus therapy within 3 days after informed consent.
• Patients who be inadequate to effect to steroid plus therapy.
• Patients with greater than or equal to twenty years old at informed consent.

Exclusion criteria

• Patients who have developed optic neuritis.
• Patients treated with intravenous immunoglobulin within 14 days before informed consent.
• Patients with malignancy at informed consent.
• Patients with history of shock or hypersensitivity for NPB-01.
• Patients with IgA deficiency.
• Patients with impaired liver function.
• Patients with impaired renal function.
• Patients with cerebro- or cardiovascular disorders.
• Patients with high risk of thromboembolism.
• Patients with hemolytic/hemorrhagic anemia.
• Patients with decreased cardiac function.
• Patients with decreased platelet.