A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
- Conditions
- neuromyelitis optica
- Registration Number
- JPRN-UMIN000010094
- Lead Sponsor
- Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patients with multiple sclerosis. 2) Patients with severe cardiac disease, severe liver disease, severe lung disease, severe gastrointestinal disease, severe kidney disease, immunodeficiency disease, or other diseases which organizer consider to be inappropriate. 3) Patients who have more than four organs dysfunction. 4) Patients who have or had asthma which requires continuous treatment. 5) Patients who have or had malignant diseases. 6) Patients who have severe autoimmune inflammatory diseases. 7) Patients with systemic infection including bacterial, viral, fungal, HBV, HCV, and HIV. 8) Patients who can not assess by MRI with gadolinium enhancement. 9) Patients who have received treatments listed below after the relapse. a. steroid pulse therapy b. plasmapheresis 10) Patients with increased serum transaminase levels. AST: higher than 5 times reference range ALT: higher than 5 times reference range 11) Patients with alcoholism. 12) Patients who had entered other clinical trials within 3 months. 13) Patients with pregnancy. 14) Patients with breastfeeding. 15) Patients who have severe allergic reactions. 16) Patients who can't cooperate with medical stuff.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Expanded Disability Status Scale (EDSS) change after 5 days treatment and one month after the treatment
- Secondary Outcome Measures
Name Time Method