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New treatment option for Neuromyelitis Optica Spectrum Disorders (NMOSD)
Official title Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
ClinicalTrials.gov ID: NCT07420296
What this study is testing
What is Eculizumab administration?
Eculizumab administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuromyelitis optica spectrum disorders (nmosd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participants ≥ 18 years of age
- Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD
- Seropositivity for anti-AQP4 antibody.
- Time from onset to enrollment ≤ 30 days.
- For patients with optic neuritis: visual acuity ≤ 20/200 at screening; for relapse cases, baseline visual acuity prior to this acute episode must...
You likely can't join if
- Patients with concurrent neuromuscular disorders.
- Patients with severe coagulation dysfunction.
- Patients with known allergy to plasma or intravenous immunoglobulin (IVIG).
- Patients with active hepatitis B or C virus infection, human immunodeficiency virus (HIV) infection, or those deemed at high risk for the onset or...
- Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections.
- Pregnant or lactating patients.
See the full eligibility criteria
- Participants ≥ 18 years of age
- Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD
- Seropositivity for anti-AQP4 antibody.
- Time from onset to enrollment ≤ 30 days.
- For patients with optic neuritis: visual acuity ≤ 20/200 at screening; for relapse cases, baseline visual acuity prior to this acute episode must have been ≥ 20/60.
- For patients with longitudinal extensive transverse myelitis (LETM): EDSS score ≥ 5.5 at screening; for relapse cases, baseline EDSS score prior to this acute episode must have been ≤ 3.5.
- Ability to understand and voluntarily provide written informed consent-
- Patients with concurrent neuromuscular disorders.
- Patients with severe coagulation dysfunction.
- Patients with known allergy to plasma or intravenous immunoglobulin (IVIG).
- 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.
- Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections.
- Pregnant or lactating patients.
- Patients with chronic, severe medical conditions that may affect study compliance.
- Patients with any clinically significant abnormal laboratory findings as determined by the investigator (e.g., severe anemia, leukopenia, thrombocytopenia, etc.).
- Patients whom the investigator considers unlikely to complete the study or unlikely to comply with the study requirements (for administrative reasons or otherwise).
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.