RecruitingNot a drug-phase studyNMOSDNCT06763848

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Protein A immunoadsorption

Compared with

  • Methylprednisolone

    Glucocorticoid receptor agonist

What it measured

Main measures

  • To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before

    Evaluation timing includes from the screening period to the baseline and the EDSS score assessment one month after starting treatment.

    Disability progression

Who could take part

NMOSD · 18 to 65

Inclusion Criteria: * The inclusion criteria for the study are as follows: 1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD) 2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions. 3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method. 4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis. 3. Participants with contraindications to intravenous methylprednisolone treatment. 4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months. 5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use. 6. Severe Bleeding or Bleeding Disorders 7. Severe Heart Failure 8. Severe Infections

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.

Papers

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History

    1. Started

      Apr 2025

    2. Main results due

      Dec 2026

    3. Finished

      Dec 2026

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