Neuromyelitis Optica Spectrum Disorder Clinical Trial
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
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.
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