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Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder

Study acronym: PANDA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Phase: Phase 4 to Not applicablev2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2025 to Apr 25, 2025
    • Site details revised
    • Collaborators revised (4)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06763848
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: Second Affiliated Hospital of Guangzhou Medical University, Guangdong 999 Brain Hospital, Second Xiangya Hospital of Central South University, Beijing Friendship Hospital
Conditions
(from sponsor)		 Neuromyelitis Optica Spectrum Disorders
Related terms Neuromyelitis Optica
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov