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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