Fatigue In Relapsing Multiple Sclerosis Epstein-Barr Virus Treatment Trial (ACTRN12624000423516)

A clinical trial assessing the impact of tenofovir alafenamide, spironolactone and placebo on fatigue in people with MS over a period of 16 weeks. Aiming to reduce the frequency of the Epstein Barr Virus DNA in saliva and improve participant reported outcome measures of disease compared to placebo.

Trial phase

Phase 3

Trial participation type

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

Principal investigator

A/Prof Mastura Monif

Key inclusion data

INCLUSION: 18-65 years old, diagnosed with Relapsing Remitting MS (RRMS), EDSS score of ?6 within the last 12 months independent of relapse, stable and have not received a new MS therapy in the preceding 8 weeks. Clinical fatigue (evidenced by a mean FSS score > 4 equivalent to an FSS score > 36 out of 63), on two occasions, 2 weeks apart. Must be low or intermediate risk for Obstructive Sleep Apnoea (OSA). EXCLUSION: Treatment in the last 6 months or due for re-treatment during the course of the study with Cladribrine or lithium. Currently taking contraindicated medication, including ACE inhibitors, iron supplements, illicit substances, psychotropic or stimulant medication commenced <4 weeks prior to study commencement. Kidney disease, gastrointestinal ulcers, renal stones, epilepsy, obstructive sleep apnoea, pregnancy or breast feeding.