Fatigue is a common symptom for many people with MS and it does not respond to traditional MS treatments. It has been suggested that fatigue in MS could relate to chronic infection with the Epstein Barr Virus (EBV). In this clinical trial, two drug therapies with antiviral effects against EBV will be tested for their effect on fatigue in people with MS. The drug therapies to be tested are tenofovir alafenamide (TAF) and spironolactone. These therapies suppress EBV infection in the laboratory, but it is not known if they suppress EBV infection in people with MS. These therapies are already approved in Australia by the Therapeutic Goods Administration to treat other conditions.

Thus, the primary aim of the trial is to demonstrate that TAF or spironolactone improve fatigue in people with MS after 16 weeks of treatment. 240 patients with relapsing remitting MS will be randomised to one of three groups: intervention with TAF (n=80), intervention with spironolactone (n=80), or placebo (n=80) for 16 weeks.

Recruting soon in NSW, VIC, QLD, WA, TAS.

• Aged between 18-65 years (inclusive), diagnosis of relapsing remitting MS by a neurologist, clinical fatigue, willingness to participate in study and comply with study requirements, available to attend 4 in-person study visits.

• Started new MS therapy in preceding 8 weeks, kidney disease, hyperthyroidism, hypothyroidism, pregnancy, taking cladribine, taking angiotensin converting enzyme inhibitors, change in psychotropic/iron supplementation/stimulant medications in preceding 4 weeks, use of any illicit substances, epilepsy, gastrointestinal ulcers or renal stones.

To determine whether you may be eligible to participate in FIRMS-EBV, an online screening portal, MS Trial Screen will be available soon.

Not yet recruiting.

TBC

Full details of the trial can be found on the ANZCTR clinical trials database under trial number ACTRN12624000423516.

NSW, VIC, QLD, WA, TAS

Yes

26/03/2025