None listed
Conditions
Brief summary
Existing Multiple Sclerosis (MS) therapies are effective at reducing MS relapses but there is currently no effective therapy for treating MS _x0002_related fatigue. There is an understanding that chronic Epstein Barr Virus (EBV) infection of immune cells, called B lymphocytes, might be a driver of chronic symptoms in MS, such as fatigue. As such, this trial examines whether treating EBV infection can improve MS-related fatigue. The study tests two 're_x0002_purposed' anti-viral drugs, 'Tenofovir alafenamide' and 'Spironolactone', as an add-on to standard MS treatment for 16 weeks to see if fatigue can improve in participants with relapsing MS. We hypothesise that both Tenofovir alafenamide and Spironolactone will improve measures of fatigue in participants with relapsing MS compared to placebo.
Interventions
Arm 1 - Spironolactone
25mg oral capsule twice daily for first week, then 50mg oral capsule twice daily for next 15 weeks.
Arm 2 - Tenofovir Alafenamide (TAF)
25mg oral capsule daily for 16 weeks.
Both interventions will be administered as an add-on to participants' usual MS treatments (disease-modifying therapies (DMT)) and they will continue taking these as prescribed by their treating doctor.
Participants will return all unused study drug including empty bottles at study visits so that com
Arm 1 - Spironolactone 25mg oral capsule twice daily for first week, then 50mg oral capsule twice daily for next 15 weeks. Arm 2 - Tenofovir Alafenamide (TAF) 25mg oral capsule daily for 16 weeks. Both interventions will be administered as an add-on to participants' usual MS treatments (disease-modifying therapies (DMT)) and they will continue taking these as prescribed by their treating doctor. Participants will return all unused study drug including empty bottles at study visits so that compliance can be checked.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Outcome results
None listed