Actively Recruiting
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Led by Tianjin Medical University General Hospital · Updated on 2025-09-22
110
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG). The objectives of this study are to assess the efficacy and safety of eculizumab for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. Eculizumab, a humanized monoclonal antibody, inhibits the terminal complement protein C5 and prevents its cleavage into C5a and the formation of C5b-9 (MAC), has approved for preventive treatment of NMOSD. Given the high efficacy of C5 inhibition, eculizumab is proposed to potentially provide rapid relief from astrocyte destruction by reducing MAC formation, which could contribute to the fast alleviation of neurological deficit during NMO acute attack. The potential of eculizumab warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks.
CONDITIONS
Official Title
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive for anti-AQP4 antibodies
- Male or female patients 18 years or older
- Body weight 35 kg or more
- Acute optic neuritis and/or transverse myelitis within 28 days from attack with at least 2-point increase in OSIS from prior attack
- Female participants not pregnant, not breastfeeding, and not intending to conceive during the trial
You will not qualify if you...
- Use of intravenous immunoglobulin (IVIg) within 3 weeks before screening
- Unresolved meningococcal infection
- Any clinically significant untreated bacterial or other infection
- Participation in another investigational drug study or exposure within 30 days
- Previous treatment with eculizumab
- Allergy to murine proteins or components of eculizumab
- Any medical condition that may interfere with participation or increase risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
F
Fu-Dong Shi
CONTACT
W
Wei Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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