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Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

Eculizumab Add-On Therapy in the Acute Phase of Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Real-World Study

NCT07410039•Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This project is a multi-center, prospective, real-world cohort study that collects clinical data of Chinese patients with AQP4-positive NMOSD in the acute stage. It comprehensively assesses the clinical outcomes of the patients and aims to compare the clinical efficacy and safety of icoxib as a combined add-on treatment versus simple hormone shock therapy during the acute phase of NMOSD.Using simple hormone shock therapy (IVMP) as the control group, the efficacy and safety of etanercept treatment in the acute attack phase of Chinese patients with AQP4-positive neuromyelitis optica spectrum disorder (NMOSD) were evaluated.

Detailed Description

Patients who met the inclusion and exclusion criteria were divided into three groups for their acute-phase treatment based on their treatment preferences: 1. Eculizumab plus treatment group: Eculizumab + IVMP (intravenous methylprednisolone pulse therapy) 2. Human immunoglobulin addition treatment group: IVIG + IVMP 3. Single IVMP treatment group: IVMP

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 - 65 years old, gender not restricted.
•2. Patients who meet the diagnostic criteria for NMOSD as set by the International Panel for NMO Diagnosis (IPND) in 2015, and have positive serum AQP4-IgG (by CBA method or live cell method).
•3. Acute phase of NMOSD-ON, defined as new or worsening optic nerve dysfunction (visual acuity decline accompanied or not by eye pain and visual field defect), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent optic nerve damage on imaging (new or expanded T2WI lesions, with enhancement); the best corrected visual acuity (BCVA) of the affected eye during the acute phase of NMOSD-ON (if both eyes are affected simultaneously, the worse eye is considered) drops from above 0.3 to ≤ 0.1.
•4. Acute phase of NMOSD-TM, defined as new or worsening spinal cord dysfunction (limb weakness or numbness, accompanied or not by urinary and defecation disorders), with an onset duration of ≤ 21 days, and clear evidence of new or recurrent spinal cord damage on imaging (new or expanded T2WI lesions, with enhancement); the EDSS score during the acute phase of NMOSD-TM increases from ≤ 4.0 to ≥ 6.0.
•5. Clinical onset and recurrence determination requires unanimous judgment by each center and the center committee (an independent group of 3 people).
•6. Agree to receive meningococcal vaccine or use eculizumab during and 2 weeks after the medication.
•7. Sign the informed consent.

Exclusion Criteria

•1. Damage to the optic nerve or spinal cord caused by other non-NMOSD-related factors.
•2. Abnormal laboratory indicators that need to be excluded from the subjects include, but are not limited to the following indicators:
•Neutrophils \< 1.5 × 109/L, Hemoglobin \< 90g/L, Platelet count \< 75 × 109/L; Serum creatinine \> 1.5 × ULN, Total bilirubin \> 1.5 × ULN, Aspartate aminotransferase (AST) \> 1.5 × ULN, Alanine aminotransferase (ALT) \> 1.5 × ULN, Alkaline phosphatase \> 2 × ULN ； HbA1c \> 8% (for diabetic patients); GFR \< 60 mL/minute/1.73m2.
•3. Pregnant or lactating women, as well as those planning to become pregnant during the study period.
•4. Those who have received PE/IA/IVIG/FcRn/B-cell deletion/C5/IL-6 treatment within 1 month before enrollment.
•5. Active infections: active hepatitis B, hepatitis C, syphilis or HIV infection; active systemic infections or immunodeficiency diseases; unrelieved meningococcal infection of the meninges, or patients with severe infections that cannot use immunosuppressive drugs.
•6. Patients with severe internal or external diseases (not limited to such as heart failure, unstable angina pectoris, respiratory failure, pulmonary insufficiency, cachexia, organ transplantation, etc.).
•7. Those who have had or currently have an untreated malignant tumor that is not well controlled.
•8. Patients with serious physical or mental diseases that may affect the smooth implementation of the study.
•9. Patients known to be allergic to monoclonal drugs, murine proteins or any excipients.
+5 more criteria

Locations (1)

the First Medical Center of Chinese PLA General Hospital

Beijing, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2029

Last Updated

March 12, 2026

Enrollment

200

ESTIMATED participants

Conditions

Neuromyelitis Optica Spectrum Disorder Attack

Interventions

Eculizumab+IVMP

DRUG

IVIG+IVMP

DRUG

IVMP

DRUG

Contacts

Dehui huang, Doctoral degree

CONTACT

+86-13911079787 huangdehui@gmail.com

Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder

NCT07184840

Neuromyelitis Optica Spectrum Disorder Attack

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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