neuromyelitis optica
Conditions
Interventions
4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Neuromyelitis optica or Neuromyelitis optica spectrum disorder who are positive for serum anti-aquaporin-4 antibody. 2) Patients who relapsed by one of the symptoms listed below. a. unilateral of bilateral optic neuritis. b. myelitis. 3) Patients whose site of lesion was detected by MRI. 4) Patients who can sign on a printed form of informed consent by themselves.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Expanded Disability Status Scale (EDSS) change after 5 days treatment and one month after the treatment | — |
Countries
Japan
Contacts
Public ContactIchiro Naksahima
Tohoku University Hospital Department of Neurology
Outcome results
None listed