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Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

RecruitingPhase 3Ages 18 Years - 80 YearsAllTianjin Medical University General Hospital
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In plain words

What the trial is, and whether it could suit you

Study Title: A National, Multicenter, Randomized Controlled Trial of the Modified Zipper Therapy in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (ELITE Study) Brief Summary: The goal of this clinical trial is to evaluate the efficacy and safety of a novel sequential immunomodulation strategy, termed "Modified Zipper Therapy," in patients with acute attacks of Aquaporin-4 antibody-positive Neuromyelitis Optica Spectrum Disorder (AQP4-IgG+ NMOSD). The therapy aims to enhance neurological recovery by combining plasma exchange (PE) with immediate complement inhibition using eculizumab, following high-dose corticosteroid pulse therapy. The main questions this trial aims to answer are: Efficacy: Does the Modified Zipper Therapy (high-dose corticosteroids + plasma exchange + eculizumab) lead to a higher rate of neurological improvement at Week 12 compared to standard therap

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participants โ‰ฅ 18 years of age 2. Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD 3. Seropositivity for anti-AQP4 antibody. 4. Time from onset to enrollment โ‰ค 30 days. 5. For patients with optic neuritis: visual acuity โ‰ค 20/200 at screening; for relapse cases, baseline visual acuity prior to this acute episode must have been โ‰ฅ 20/60. 6. For patients with longitudinal extensive transverse myelitis (LETM): EDSS score โ‰ฅ 5.5 at screening; for relapse cases, baseline EDSS score prior to this acute episode must have been โ‰ค 3.5. 7. Ability to understand and voluntarily provide written informed consent- Exclusion Criteria: 1. Patients with concurrent neuromuscular disorders. 2. Patients with severe coagulation dysfunction. 3. Patients with known allergy to plasma or intravenous immunoglobulin (IVIG). 4. Patients with active hepatitis B or C virus infection, human immunodeficiency virus (HIV) infection, or those deemed at high risk for the onset or reactivation of syphilis or tuberculosis at screening. 5. Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections. 6. Pregnant or lactating patients. 7. Patients with chronic, severe medical conditions that may affect study compliance. 8. Patients with any clinically significant abnormal laboratory findings as determined by the investigator (e.g., severe anemia, leukopenia, thrombocytopenia, etc.). 9. Patients whom the investigator considers unlikely to complete the study or unlikely to comply with the study requirements (for administrative reasons or otherwise).
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What it tests

  • Eculizumab administration
  • High-dose corticosteroid pulse therapy
  • Plasma exchange (PE)
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Where

1 site
Tianjin Medical University General Hospital, Department of Neurology
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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