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Journal article
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
BMJ neurology open, Vol.7(2), e001313
2025
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).
Details
- 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
- Authors/Creators
- Kayla Ward - Gold Coast HospitalVivien Li - Florey Institute of Neuroscience and Mental HealthSudarshini Ramanathan - Concord Repatriation General HospitalLesley-Ann Hall - Flinders UniversityKatherine Buzzard - Monash UniversityKaylene Young - University of TasmaniaFiona Mckay - Multiple Sclerosis Research InstituteVanessa Vigar - Griffith UniversitySabrina Oishi - Griffith UniversityLidia Madrid San Martin - Griffith UniversityBelinda Kaskow - Perron Institute for Neurological and Translational ScienceGrant Parnell - Westmead Institute for Medical ResearchJulie A. Campbell - University of TasmaniaJing Sun - Griffith UniversityCorey Smith - QIMR Berghofer Medical Research InstituteVilija Jokubaitis - Monash UniversityTomas Kalincik - The University of MelbourneDavid Tscharke - Australian National UniversityAndrew Potter - Multiple Sclerosis SocietyErin Brady - Multiple Sclerosis SocietyJeannette Lechner-Scott - John Hunter HospitalLawrence Steinman - Stanford UniversityMahesh Parmar - University College LondonJeremy Chataway - UCL Queen Square Institute of NeurologyTodd Hardy - Cooperative Trials Group for Neuro-OncologyWilliam M. Carroll - Perron Institute for Neurological and Translational ScienceMichael H. Barnett - Cooperative Trials Group for Neuro-OncologyBruce V. Taylor - University of TasmaniaSimon A. Broadley - Gold Coast HospitalSuzanne HodgkinsonHelmut ButzkuevenRajiv KhannaAllan G KermodeScott ByrneAnneke van der WaltSean RimintonMarzena PedriniStefan BlumStephanie TrendHeidi BeadnallZara IoannidesNevin JohnIzanne RoosJanakan RavindranTim WangTrevor J KilpatrickAnne-Louise PonsonbyPam A McCombeRichard A L MacdonellTri PhanSilvana GaudieriJohn D ParrattAnne BruestleSteven PetratosSanjay SwaminathanVicki MaltbyYuan ZhouMastura MonifJoshua BartonChhavi AsthanaLauren GilesJulia MorahanNigel CaswellAmit Bar-OrMichael LevyGavin Giovannoni
- Publication Details
- BMJ neurology open, Vol.7(2), e001313
- Publisher
- BMJ Publishing Group Ltd
- Number of pages
- 15
- Grant note
- MRFF 2025006 / National Health and Medical Research Council (http://dx.doi.org/10.13039/501100000925)
- Identifiers
- 991005839954307891
- Copyright
- © Author(s) (or their employer(s)) 2025.
- Murdoch Affiliation
- Institute for Immunology and Infectious Diseases; Personalised Medicine Centre
- Language
- English
- Resource Type
- Journal article
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