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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04064944
Other study ID # 20190705
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2024

Study information

Verified date August 2019
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Wei Qiu
Phone 0086- 15899968330
Email qw9406@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 144
Est. completion date December 31, 2024
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)

2. When NMOSD Patients with acute attacks undergo a course of hormone shock therapy (5-10g total methylprednisolone), EDSS = 6.0 or visual acuity = 20/200

3. Serum AQP4-IgG positive (CBA test)

Exclusion Criteria:

1. Weight <25Kg

2. Nursing or pregnant women

3. Unable to establish a peripheral or central vascular access

4. The use of rituximab and gamma-ball shocks within 3 months prior to enrollment

5. Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment

6. ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped

Study Design


Related Conditions & MeSH terms


Intervention

Device:
blood purification equipment
The subjects enrolled in this study will undergo blood purification treatment, and will be randomized into either immunoadsorption group or 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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University Guangdong 999 Brain Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in EDSS scores Changes in EDSS scores of 4 weeks after the last treatment of plasma exchange or immunoadsorption compared with the first treatment 4 weeks after the last treatment vs.baseline ( first treatment)
Secondary Comparison of follow-up results of EDSS scores Comparation of the changes in EDSS scores of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Secondary Comparison of follow-up results of LogMAR Comparation of the changes in LogMAR of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment (NMO patients) the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Secondary Comparison of follow-up results of AQP4-IgG level Comparation of the changes in AQP4-IgG level of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
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