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NCT04064944: CAMPUS

Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders

Status unknown Phase 2 Last updated 22 August 2019
What this trial tests

Phase 2 trial testing blood purification equipment in Neuromyelitis Optica Spectrum Disorder in 144 participants. Status unknown.

Timeline
1 September 2019
Primary endpoint
1 August 2023
31 December 2024

Quick facts

Lead sponsorThird Affiliated Hospital, Sun Yat-Sen University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment144
Start date1 September 2019
Primary completion1 August 2023
Estimated completion31 December 2024

Drugs / interventions tested

Conditions studied

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Who can join

Adults 14 to 65, any sex, with Neuromyelitis Optica Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies.
    Carnero Contentti E, Correale J. · · 2021 · cited 202× · PMID 34530847 · DOI 10.1186/s12974-021-02249-1
  2. Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.
    Saitakis G, Chwalisz BK. · · 2022 · cited 9× · PMID 36077167 · DOI 10.3390/ijms23179769
  3. B Cells and Antibodies as Targets of Therapeutic Intervention in Neuromyelitis Optica Spectrum Disorders.
    Traub J, Husseini L, Weber MS. · · 2021 · cited 9× · PMID 33419217 · DOI 10.3390/ph14010037

Verify or expand the search:

Other recruiting trials for Neuromyelitis Optica Spectrum Disorder

Currently open trials in the same condition.

Other Third Affiliated Hospital, Sun Yat-Sen University trials

Trials by the same sponsor.

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Data sources for this page

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