Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-04 @ 12:06 AM
Study NCT ID:
NCT06673394
Status:
WITHDRAWN
Last Update Posted:
2025-09-10
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder
Sponsor:
Tianjin Medical University General Hospital
Organization:
Study Overview
Official Title:
Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder (NMOSD): a Multi-Center, Phase 2, Open Label Trial (EASE-NMO)
Status:
WITHDRAWN
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE-NMO
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: