Status:
COMPLETED
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.
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 confl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01845584
Start Date
May 1 2013
End Date
August 1 2015
Last Update
April 12 2017
Active Locations (1)
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1
Japan
Osaka, Japan