RecruitingPhase 2Phase 3ACTRN12625000095460

TRI-ME: Trimetazidine to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A double-blind, randomised, placebo-controlled efficacy trial


Sponsor

Deakin University

Enrollment

126 participants

Start Date

Jun 4, 2025

Study Type

Interventional

Conditions

Summary

Existing treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are inadequate and ME/CFS therapy represents an unmet need of healthcare. Our aim is to assess the efficacy of trimetazidine, a metabolic agent, in treating ME/CFS in a double-blind, randomised, placebo-controlled clinical trial. Mitochondrial dysfunction has long been associated with inflammation and oxidative stress of ME/CFS and may be the potential final common pathway in the pathophysiology of ME/CFS. Trimetazidine increases metabolic efficiency in the mitochondria by promoting glucose oxidation rather than fatty acid oxidation (i.e. increased energy generation) and has anti-inflammatory and antioxidant properties. Importantly, in preclinical rodent studies confirmed trimetazidine increases mitochondrial function in the brain and facilitates longer swimming in the forced swim test without causing hyperactivity in the large open field. Trimetazidine was also identified using an atheoretical drug screening approach that showed trimetazidine to redress mitochondrial dysfunction. The therapeutic potential of trimetazidine is clear, Trimetazidine is highly accessible, affordable, and has regulatory approval to treat angina in Asia and Europe, making it particularly suitable to repurpose for ME/CFS.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a serious, long-term illness causing profound fatigue that is made worse by activity, unrefreshing sleep, cognitive difficulties (brain fog), and post-exertional malaise. Despite affecting hundreds of thousands of Australians, ME/CFS has no approved treatments, and current management is largely focused on symptom management rather than addressing the underlying biology of the condition. This study is trialling trimetazidine — an existing medication approved in Europe and Asia for treating angina (heart pain) — as a potential treatment for ME/CFS. Trimetazidine works by improving how the mitochondria (the 'energy factories' of cells) produce energy, and has anti-inflammatory and antioxidant properties. Participants will take either trimetazidine or a placebo twice daily for 12 weeks and be assessed for changes in fatigue, function, and quality of life. You may be eligible if you are aged 18 or older, meet the Canadian Consensus Criteria for ME/CFS diagnosis, have a current treating physician, and are willing and able to give informed consent. People with severe kidney disease, Parkinson's disease, restless legs syndrome, current major psychiatric disorders, pregnancy, or who are currently enrolled in another clinical trial would not be eligible.

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Interventions

1) Intervention: Trimetazidine 2) Dose: a single 35mg tablet per dose, twice daily. 3) Duration: 8 weeks. 4) Mode of Administration: Oral tablet. 5) Adherence monitoring: Participants are require

1) Intervention: Trimetazidine 2) Dose: a single 35mg tablet per dose, twice daily. 3) Duration: 8 weeks. 4) Mode of Administration: Oral tablet. 5) Adherence monitoring: Participants are required to return all medication bottles for double tablet count by the trial pharmacist and trial coordinator.


Locations(1)

VIC, Australia

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