Clinical trial of anti-Epstein-Barr virus therapies for the prevention of progression in multiple sclerosis

Phase 3

• Conditions: Multiple sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12623000849695
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 350

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
•Available to attend clinic visits

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 (if female)
•Currently breast feeding (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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage 1 - Co-primary endopoint of frequency of salivery EBV DNA detection in monthly samples and serum EBNA1 antibody titres in serum[ Stage 1 - 6 months post-commencement of intervention];Stage 2 - Time to 6 month confirmed disability progression (CDP) using a composite of expanded disability status scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Pet Test (9-HPT)[ Stage 2 - Time to event analysis, with mean follow up of 3 years post-commencement of intervention (assessed every 6 months for the duration of the study for up to 5 years post-commencement of the study)]