Efgartigimod in Acute Neuromyelitis Optica Spectrum Disorders

Sponsor
Feng Jinzhou
Study ID
NCT06118398
Status
Unknown

Conditions

  • Efgartigimod
  • Neuromyelitis Optica

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous methylprednisolone (IVMP) and Efgartigimod — DRUG
    IVMP 800-1000mg/day for 3-5 days plus Efgartigimod (Efgartigimod: 10mg/kg IV on Day 1, Day 8, Day 15 and Day 22 after IVMP.)
  • IVMP — DRUG
    IVMP 800-1000mg/day for 3-5 days.

Study Details

This study aims to retrospective investigate the safety and effectiveness of Efgartigimod in the acute phase of neuromyelitis optica spectrum disorders (NMOSD) patients.

Key Dates

Start date
Nov 5, 2023
Status verified
Nov 2023
Primary completion
Nov 5, 2024
Completion
May 5, 2025

Study Design

Enrollment
24 participants (estimated)

Arms

  • Arm: Exposed group
    Intravenous methylprednisolone (IVMP) plus Efgartigimod
  • Arm: Control group
    IVMP

Primary Outcome Measure

Change in Expanded Disability Status Scale (EDSS) score from baseline. [ Time Frame: 1 month ]

Central Contacts

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