Clinical Trial

Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder

Study acronym: SIVAR-NMOSD
Not Yet Recruiting Phase 1/2
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Summary
The primary objective of this study is to evaluate the safety and tolerability of sivelestat sodium hydrate administered in combination with standard steroid pulse therapy in patients experiencing an acute NMOSD attack. Safety assessments will include adverse events, laboratory parameters, vital signs, and other clinically relevant findings. In addition, the study will explore whether the addition of sivelestat sodium hydrate to standard steroid pulse therapy improves neurological outcomes in patients with acute NMOSD. Participants will receive intravenous sivelestat sodium hydrate at a dose of 4.8 mg/kg/day administered as a continuous infusion (0.2 mg/kg/hour) for 5 consecutive days, receive steroid pulse therapy according to the study protocol, and be followed for 28 days after treatment initiation for safety and efficacy evaluations.
Trial Details
NCT Number NCT07738952
Lead Sponsor Kyushu University
Conditions Neuromyelitis Optica Spectrum Disorder Attack
Enrollment 7 participants
Start Date 2026-08-17
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-31