Status:
UNKNOWN
Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangdong 999 Brain Hospital
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
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, ...
Eligibility Criteria
Inclusion
- Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)
- 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
- Serum AQP4-IgG positive (CBA test)
Exclusion
- Weight \<25Kg
- Nursing or pregnant women
- Unable to establish a peripheral or central vascular access
- The use of rituximab and gamma-ball shocks within 3 months prior to enrollment
- Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment
- ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04064944
Start Date
September 1 2019
End Date
December 31 2024
Last Update
August 22 2019
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