None listed
Conditions
Brief 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.
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 required to return all medication bottles for double tablet count by the trial pharmacist and trial coordinator.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Aged 18 years or above; 2) Fulfil the criteria Canadian Consensus Criteria44 for ME/CFS diagnosis; 3) Willing and able to give informed consent prior to study enrolment and to comply with study procedures; 4) Ongoing use of contraception (if sexually active and of childbearing potential age); 5) Nominate a current treating physician.
Exclusion criteria
1) A known or suspected active and unstable systemic medical disorder that is deemed to affect the participant safety to enrol, determined by the PI or their delegate; 2) Any history of severe renal disease (e.g. eGFR < 30, renal failure), Parkinson’s disease, restless legs syndrome or other movement disorders; 3) A DSM-5 diagnosis of a current major psychiatric disorder (e.g., any of psychotic, bipolar, substance dependence, eating, or significant personality disorders); 4) Be currently pregnant or breastfeeding; 5) Have contraindications or intolerance or allergy to trimetazidine; 6) Initiate cognitive behavioural therapy and/or graded exercise, or other evidence-based treatments that may affect ME/CFS symptoms within 4 weeks before study entry; 7) Concurrently enrolled in another clinical trial; 8) Inability to comply with either the requirements of informed consent or the treatment protocol; 9) Current concomitant use of Monoamine oxidase inhibitors. 10) A clinically significant reading from safety blood tests that deem the participant ineligible, at a medically qualified site principal investigator’s discretion.
Outcome results
None listed