Phase III, multicentre, randomised, double-blinded, placebo-controlled, MAMS trial of SpironolacTone and famciclOvir in the treatment of Progressive MS to prevent disability progression (STOP-MS) (ACTN12621001502820)

We have selected two potential anti-Epstein-Barr virus therapies (spironolactone and famciclovir) to test in an innovative multi-stage, multi-arm trial in order to identify the best treatment for progressive MS. Treatments will be compared to dummy-treatment.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Anneke van der Walt

Key inclusion data

Inclusion Criteria: Age 25-70 years (inclusive), Diagnosed with primary or secondary progressive MS according to McDonald 2017 criteria, EDSS of 4.0 – 8.0 (inclusive) at the time of randomisation, Evidence of disability progression over the previous 24 months, English speaking or non-English speaking but can ensure external interpreter assistance (e.g. relative or friend) to attend all visits for the duration of the clinical trial. Exclusion Criteria: A clinical relapse within 3 months of randomisation, A significant co-morbidity that in the opinion of the principal investigator (PI) would negatively affect MS disease outcomes or preclude administration of spironolactone or famciclovir (including renal failure; estimated glomerular filtration rate < 30ml/min), Hypersensitivity to spironolactone or famciclovir , Pregnant or currently breastfeeding (if female); Have received treatment with steroids (intravenous and/or oral) for MS relapse/progression within 3 months before randomisation; Have received any trial therapy within the last 6 months (other than as part of the STOP-MS Stage 1 trial); Unwilling or unable to use appropriate contraception for the treatment phase of the study (Up to 3 years) – if female; Recent or current history of major depression, bipolar disorder, psychosis or suicidality; Currently or recently taking any illicit substances (including any cannabis product).