PANDA
What it found
No result yet.
What was tested
Treatment tested
- Protein A immunoadsorption
Compared with
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before
Evaluation timing includes from the screening period to the baseline and the EDSS score assessment one month after starting treatment.
Disability progression
Who could take part
NMOSD · 18 to 65
Inclusion Criteria: * The inclusion criteria for the study are as follows: 1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD) 2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions. 3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method. 4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis. 3. Participants with contraindications to intravenous methylprednisolone treatment. 4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months. 5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use. 6. Severe Bleeding or Bleeding Disorders 7. Severe Heart Failure 8. Severe Infections
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
Background
Li R, Wang J, Li C, Liu X, Chu M, Chang Y, Wang Y, Wang X, Yu B, Ling L, Yang H, Yang H, Hu X, Qiu W. Rescue immunoadsorption treatment for neuromyelitis optica spectrum disorder attacks unresponsive to intravenous methylprednisolone. J Neuroimmunol. 2021 Jul 15;356:577604. doi: 10.1016/j.jneuroim.2021.577604. Epub 2021 May 7.Background
Kleiter I, Gahlen A, Borisow N, Fischer K, Wernecke KD, Wegner B, Hellwig K, Pache F, Ruprecht K, Havla J, Krumbholz M, Kumpfel T, Aktas O, Hartung HP, Ringelstein M, Geis C, Kleinschnitz C, Berthele A, Hemmer B, Angstwurm K, Stellmann JP, Schuster S, Stangel M, Lauda F, Tumani H, Mayer C, Zeltner L, Ziemann U, Linker R, Schwab M, Marziniak M, Then Bergh F, Hofstadt-van Oy U, Neuhaus O, WinkelmannBackground
Kleiter I, Gahlen A, Borisow N, Fischer K, Wernecke KD, Hellwig K, Pache F, Ruprecht K, Havla J, Kumpfel T, Aktas O, Hartung HP, Ringelstein M, Geis C, Kleinschnitz C, Berthele A, Hemmer B, Angstwurm K, Stellmann JP, Schuster S, Stangel M, Lauda F, Tumani H, Mayer C, Krumbholz M, Zeltner L, Ziemann U, Linker R, Schwab M, Marziniak M, Then Bergh F, Hofstadt-van Oy U, Neuhaus O, Zettl UK, Faiss J, WBackground
Trebst C, Jarius S, Berthele A, Paul F, Schippling S, Wildemann B, Borisow N, Kleiter I, Aktas O, Kumpfel T; Neuromyelitis Optica Study Group (NEMOS). Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS). J Neurol. 2014 Jan;261(1):1-16. doi: 10.1007/s00415-013-7169-7. Epub 2013 Nov 23.Background
Lennon VA, Wingerchuk DM, Kryzer TJ, Pittock SJ, Lucchinetti CF, Fujihara K, Nakashima I, Weinshenker BG. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet. 2004 Dec 11-17;364(9451):2106-12. doi: 10.1016/S0140-6736(04)17551-X.Background
Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, de Seze J, Fujihara K, Greenberg B, Jacob A, Jarius S, Lana-Peixoto M, Levy M, Simon JH, Tenembaum S, Traboulsee AL, Waters P, Wellik KE, Weinshenker BG; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul 14;85(2):177-89. doi: 10.1212
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History
Started
Apr 2025
Main results due
Dec 2026
Finished
Dec 2026
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