Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04064944
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-08-22
First Post:
2019-08-20
Brief Title:
Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders a Prospective Multicenter Single-blind Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMPUS
Brief Summary:
Neuromyelitis optica spectrum disorder NMOSD is one common demyelinating disease of the central nervous system in young adults with high rate of disability and recurrence and poor natural course which can cause a serious burden on families and society To today there is still a lack of prospective multi-center large sample clinical trial evidence for the treatment and prognosis of acute attack of NMOSD patients This study will conduct a prospective multi-center single-blind randomized controlled clinical trial of acute attacked NMOSD patients in China The researchers plan to collect 144 NMOSD patients with acute attack in three research centers of Guangzhou the Third Affiliated Hospital of Sun Yat-sen University the Zhongshan Ophthalmic Center of Sun Yat-sen University and the Guangdong 999 Brain hospital to study the safety and efficacy of immunoadsorption therapy
The subjects will be randomized into immunoadsorption group and plasma exchange group and the following indicators will be evaluated 1 changes in EDSS scores and visual acuity before and after treatment 2 changes in AQP4-IgG levels 3 the safety of immunoadsorption treatment
This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients
The subjects will be randomized into immunoadsorption group and plasma exchange group and the following indicators will be evaluated 1 changes in EDSS scores and visual acuity before and after treatment 2 changes in AQP4-IgG levels 3 the safety of immunoadsorption treatment
This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None