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.

Launched by NIHON PHARMACEUTICAL CO., LTD · Apr 30, 2013

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who become positive for anti-aquaporin 4 antibody or have becomed.
• • 2. Patients who have developed myelitis.
• • 3. Patients who run beyond greater than 30 days at least from last time in relapse.
• • 4. Patients who new neurological symptom or worsening neurological symptom or flared neurological symptom have sustained 24 hours at least not associated fever or infection.
• • 5. Patients who have an acute exacerbation at informed consent.
• • 6. Patients who need steroid plus therapy（1g/day for five consecutive days）.
• • 7. Patients who can start steroid plus therapy within 3 days after informed consent.
• • 8. Patients who be inadequate to effect to steroid plus therapy.
• • 9. Patients with greater than or equal to twenty years old at informed consent.
• Exclusion Criteria:
• • 1. Patients who have developed optic neuritis.
• • 2. Patients treated with intravenous immunoglobulin within 14 days before informed consent.
• • 3. Patients with malignancy at informed consent.
• • 4. Patients with history of shock or hypersensitivity for NPB-01.
• • 5. Patients with IgA deficiency.
• • 6. Patients with impaired liver function.
• • 7. Patients with impaired renal function.
• • 8. Patients with cerebro- or cardiovascular disorders.
• • 9. Patients with high risk of thromboembolism.
• • 10. Patients with hemolytic/hemorrhagic anemia.
• • 11. Patients with decreased cardiac function.
• • 12. Patients with decreased platelet.