Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder (NCT06673394) | Clinical Trial Compass
WithdrawnPhase 2
Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder
Stopped: The study plan need to be modified after widely discussion with our consultation board, regarding the conscern about the efficiency may not be able to detect the expected differences. We would like to withdraw this study plan and startup a new one.
0Started 2025-09-03
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Anti-AQP4 antibody seropositive.
✓. Male or female patients ≥18 years old
✓. Body weight ≥ 35 kg
✓. Leukocyte and CRP in the normal range
✓. Acute optic neuritis and/or transverse myelitis presenting to the hospital within 10 days of symptom onset. An acute CNS inflammatory attack is defined as:
✓. A female subject is eligible to enter the trial if she is:
Exclusion criteria
✕. Current evidence or known history of clinically significant infection including:
✕. Current malignancy or history of malignancy in remission within the past 5 years, except for
✕. Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric, or neurological disease which could affect the subject's safety, impair the subject's reliable participation in the trial, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol, as determined by the principal investigator of the trial.
What they're measuring
1
Mean change in OSIS from presentation to Day 28
Timeframe: Acute attack to week4
Trial details
NCT IDNCT06673394
SponsorTianjin Medical University General Hospital
✕. Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives or duration of biological effect (whichever is longer) prior to screening.