Fatigue In Relapsing Multiple Sclerosis Epstein Barr Virus Treatment Trial (FIRMS EBV) - Comparing Spironolactone, Tenofovir Alafenamide and Placebo

The University of Sydney0 个研究点目标入组 240 人开始时间: 2024年4月8日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•1. Male and female participants aged 18-65 years
•2. Diagnosed with relapsing remitting Multiple Sclerosis (MS) by a neurologist
•3. Expanded Disability Status Scale (EDSS) score of 6 within the last 12 months in the absence of an acute relapse or illness
•4. Stable and have not received a new MS therapy in the preceding 8 weeks
•5. Willingness to provide informed consent and willingness to participate and comply with the study requirements
•6. Available to attend clinic visits within 1 week of each time point (baseline, Weeks 6, 16, and 20)
•7. Clinical fatigue (evidenced by an FSS score greater than 4 on two occasions when completing the test serially online or in person over a fortnight)

•1. Participants treated with the MS disease-modifying therapy, cladribine (since TAF interacts with this drug) or the mood stabilizing agent, lithium (which interacts with spironolactone)
•2. Treatment with angiotensin converting enzyme inhibitors or angiotensin 2 receptor blockers
•3. A systemic medical disorder such as kidney disease or new diagnosis of hyper- or hypothyroidism OR any medical condition that may affect adherence to the trial intervention
•4. Psychotropic medications if commenced < 4 weeks prior to study entry
•5. Currently pregnant or lactating or if of child bearing potential, unwilling to take adequate contraception measures to prevent pregnancy for the duration of the clinical trial and for 2 weeks after trial completion
•6. Commenced or are scheduled to commence iron supplementation
•7. Acute suicidality (as per the Quick Inventory of Depressive Symptomology Tool) or a current diagnosis of substance abuse/dependence
•8. Currently taking any illicit substances including any cannabis product (e.g. cannabis oil)
•9. Recent gastrointestinal ulcers or renal stones
•10. Epilepsy
•11. Current use of any of the study drugs
•12. Unable or unlikely to attend the required study visits at the required timepoints or unable to complete the study protocol
•13. Lacks the capacity to consent as determined by the treating clinician

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