{
  "abstract": "Introduction Targeting progressive multiple sclerosis (MS) addresses the current single biggest unmet need in the MS therapeutic landscape and anti-Epstein-Barr virus (EBV) therapy potentially strikes at the root cause. The SpironolacTone and famciclOvir in the treatment of Progressive MS to prevent disability progression (STOP-MS) trial has been developed to assess anti-EBV therapies in the treatment of progressive MS.Methods and analysis STOP-MS is a multi-arm, multi-stage, randomised, double-blind, placebo-controlled trial testing spironolactone and famciclovir to prevent disability progression in MS. Australians with progressive forms of MS, aged 25 to 70 years with established disability, are eligible. Recruitment commenced in March 2025 and the first participant was enrolled on 15 April 2025. The sample size for STOP-MS is 150 in stage 1 and 300 in stage 2. In stage 1, the composite primary outcome measures will be reduction of EBV DNA in saliva and serum EBV nuclear antigen-1 antibody titres. Minimum criteria for consideration of progression to stage 2 will be a 10% reduction in the composite outcome measure. In stage 2, the primary outcome measure will be 6-month confirmed disability progression analysed using Cox-proportional hazards.Trial registration number The STOP-MS trial has been acknowledged by the Therapeutics Goods Administration under the Clinical Trial Notification scheme (CT-2023-CTN-03 505-1) and is registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623000849695).",
  "authors": [
    {
      "affiliations": [
        "School of Medicine and Dentistry, Griffith University - Gold Coast Campus, Southport, Queensland, Australia",
        "Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia"
      ],
      "name": "Kayla Ward"
    },
    {
      "affiliations": [
        "The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia"
      ],
      "name": "Vivien Li"
    },
    {
      "affiliations": [
        "Translational Neuroimmunology Group, Kids Neuroscience Centre and ANZAC Research Institute, The University of Sydney Sydney Medical School, Sydney, New South Wales, Australia",
        "Department of Neurology, Concord Hospital, Concord, New South Wales, Australia"
      ],
      "name": "Sudarshini Ramanathan"
    },
    {
      "affiliations": [
        "Flinders Medical Centre, Flinders University, Adelaide, South Australia, Australia"
      ],
      "name": "Lesley-Ann Hall"
    },
    {
      "affiliations": [
        "Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia"
      ],
      "name": "Katherine Buzzard"
    },
    {
      "affiliations": [
        "Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia"
      ],
      "name": "Kaylene Young"
    },
    {
      "affiliations": [
        "Multiple Sclerosis Australia, Multiple Sclerosis Australia, Summer Hill, New South Wales, Australia"
      ],
      "name": "Fiona Mckay"
    },
    {
      "affiliations": [
        "School of Medicine, Griffith University - Gold Coast Campus, Southport, Queensland, Australia",
        "National Centre for Naturopathic Medicine, Southern Cross University, Lismore, New South Wales, Australia"
      ],
      "name": "Vanessa Vigar"
    },
    {
      "affiliations": [
        "School of Medicine, Griffith University - Gold Coast Campus, Southport, Queensland, Australia"
      ],
      "name": "Sabrina Oishi"
    },
    {
      "affiliations": [
        "School of Medicine and Dentistry, Griffith University - Gold Coast Campus, Southport, Queensland, Australia"
      ],
      "name": "Lidia Madrid San Martin"
    },
    {
      "affiliations": [
        "Perron Institute for Neurological and Translational Science, Nedlands, Western Australia, Australia"
      ],
      "name": "Belinda Kaskow"
    },
    {
      "affiliations": [
        "Centre for Immunology and Allergy Research, Westmead Institute for Medical Research, Westmead, New South Wales, Australia",
        "Infection, Immunity and Inflammation Group, School of Medical Sciences, The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Grant Parnell"
    },
    {
      "affiliations": [
        "University of Tasmania Menzies Institute for Medical Research, Hobart, Tasmania, Australia"
      ],
      "name": "Julie A. Campbell"
    },
    {
      "affiliations": [
        "School of Medicine and Dentistry, Griffith University - Gold Coast Campus, Southport, Queensland, Australia",
        "Rural Health Research Institute, Charles Sturt University, Albury, New South Wales, Australia"
      ],
      "name": "Jing Sun"
    },
    {
      "affiliations": [
        "QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia"
      ],
      "name": "Corey Smith"
    },
    {
      "affiliations": [
        "Department of Neuroscience, Monash University Central Clinical School, Melbourne, Victoria, Australia"
      ],
      "name": "Vilija Jokubaitis"
    },
    {
      "affiliations": [
        "CORe, The University of Melbourne Department of Medicine RMH, Parkville, Victoria, Australia",
        "Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Tomas Kalincik"
    },
    {
      "affiliations": [
        "Immunology and Infectious Diseases, Australian National University The John Curtin School of Medical Research, Canberra, Australian Capital Territory, Australia"
      ],
      "name": "David Tscharke"
    },
    {
      "affiliations": [
        "Multiple Sclerosis Australia, Summer Hill, New South Wales, Australia"
      ],
      "name": "Andrew Potter"
    },
    {
      "affiliations": [
        "Multiple Sclerosis Australia, Summer Hill, New South Wales, Australia"
      ],
      "name": "Erin Brady"
    },
    {
      "affiliations": [
        "Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia",
        "The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, Australia"
      ],
      "name": "Jeannette Lechner-Scott"
    },
    {
      "affiliations": [
        "Departments of Neurology and Neurological Sciences, Stanford University, Stanford, California, USA"
      ],
      "name": "Lawrence Steinman"
    },
    {
      "affiliations": [
        "ACORD at MRC Clinical Trials Unit, University College London Institute of Clinical Trials and Methodology, London, UK"
      ],
      "name": "Mahesh Parmar"
    },
    {
      "affiliations": [
        "ACORD at MRC Clinical Trials Unit, University College London Institute of Clinical Trials and Methodology, London, UK",
        "NIHR University College London Hospitals Biomedical Research Centre, London, UK",
        "Queen Square Multiple Sclerosis Centre, Department of Inflammation, UCL Queen Square Institute of Neurology, London, UK"
      ],
      "name": "Jeremy Chataway"
    },
    {
      "affiliations": [
        "Department of Neurology, Concord Repatriation General Hospital, Concord, New South Wales, Australia",
        "The University of Sydney Brain and Mind Centre, Camperdown, New South Wales, Australia"
      ],
      "name": "Todd Hardy"
    },
    {
      "affiliations": [
        "Perron Institute for Neurological and Translational Science, Nedlands, Western Australia, Australia",
        "Department of Neurology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia"
      ],
      "name": "William M. Carroll"
    },
    {
      "affiliations": [
        "The University of Sydney Brain and Mind Centre, Camperdown, New South Wales, Australia",
        "The University of Sydney Sydney Medical School, Sydney, New South Wales, Australia"
      ],
      "name": "Michael H. Barnett"
    },
    {
      "affiliations": [
        "University of Tasmania Menzies Institute for Medical Research, Hobart, Tasmania, Australia"
      ],
      "name": "Bruce V. Taylor"
    },
    {
      "affiliations": [
        "School of Medicine and Dentistry, Griffith University - Gold Coast Campus, Southport, Queensland, Australia",
        "Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia"
      ],
      "name": "Simon A. Broadley"
    },
    {
      "affiliations": [],
      "name": "Australian Multiple Sclerosis Clinical Trials Consortium"
    }
  ],
  "title": "Study protocol for a multicentre, randomised, double-blinded, placebo-controlled, multi-arm, multi-stage, trial of SpironolacTone and famciclOovir in the treatment of Progressive Multiple Sclerosis to prevent disability progression: the STOP-MS trial",
  "uid": "2cef528c-63db-5da3-b9b8-f596bf4d0140"
}