Efficacy of Reducing Fatigue In Relapsing Multiple Sclerosis: An Epstein Barr Virus Treatment Trial (FIRMS EBV)

Phase 3

• Conditions: Multiple Sclerosis; Epstein Barr Virus; Neurological - Multiple sclerosis; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12624000423516
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue[Modified Fatigue Impact Scale Baseline and after 16 weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
Fatigue[Fatigue Severity Scale Baseline and after 16 weeks of treatment]