Who is sponsoring NCT04788745?

NCT04788745 is sponsored by The University of Queensland.

What drugs are being tested in NCT04788745?

Interventions in NCT04788745: Trimetazidine Dihydrochloride.

What condition does NCT04788745 study?

NCT04788745 studies Amyotrophic Lateral Sclerosis, Motor Neuron Disease.

Is NCT04788745 still recruiting?

NCT04788745 is currently completed. Last updated 20 July 2023.

Last reviewed 2023-07-20 · How we verify

NCT04788745: MetFlex

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)

Completed Phase 2 Last updated 20 July 2023

What this trial tests

Phase 2 trial testing Trimetazidine Dihydrochloride in Amyotrophic Lateral Sclerosis in 21 participants. Completed in 24 May 2023.

Timeline

29 June 2021

Primary endpoint
24 May 2023

24 May 2023

Quick facts

Lead sponsor	The University of Queensland
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	29 June 2021
Primary completion	24 May 2023
Estimated completion	24 May 2023
Sites	3 locations across United Kingdom, Netherlands, Australia

Drugs / interventions tested

Trimetazidine Dihydrochloride — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Motor Neuron Disease — all drugs for Motor Neuron Disease →

Sponsor

The University of Queensland

Who can join

Adults 18 to 75, any sex, with Amyotrophic Lateral Sclerosis or Motor Neuron Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

MetFlex is an investigator led, open-label, single-arm, Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

An Overview of Oxidative Stress, Neuroinflammation, and Neurodegenerative Diseases.
Teleanu DM, Niculescu AG, Lungu II, Radu CI, et al · · 2022 · cited 672× · PMID 35682615 · DOI 10.3390/ijms23115938
The Advent of Omics Sciences in Clinical Trials of Motor Neuron Diseases.
Ruffo P, Cavallaro S, Conforti FL. · · 2022 · cited 8× · PMID 35629180 · DOI 10.3390/jpm12050758
Genetic and Mechanistic Insights Inform Amyotrophic Lateral Sclerosis Treatment and Symptomatic Management: Current and Emerging Therapeutics and Clinical Trial Design Considerations.
Quigley SE, Quigg KH, Goutman SA. · · 2025 · cited 2× · PMID 40897992 · DOI 10.1007/s40263-025-01217-0
Latest progress and challenges in drug development for degenerative motor neuron diseases.
Wen X, Lan T, Su W, Cao B, et al · · 2026 · cited 2× · PMID 40364643 · DOI 10.4103/nrr.nrr-d-24-01266
An open-label Phase 2a study to assess the safety and tolerability of trimetazidine in patients with amyotrophic lateral sclerosis.
van Eijk RPA, Steyn FJ, Janse van Mantgem MR, Schmidt A, et al · · 2025 · cited 2× · PMID 40008327 · DOI 10.1093/braincomms/fcaf063
The positive impact on translational research of Fondazione italiana di ricerca per la Sclerosi Laterale Amiotrofica (AriSLA), a non-profit foundation focused on amyotrophic lateral sclerosis. Convergence of ex-ante evaluation and ex-post outcomes when goals are set upfront.
Guareschi S, Ravasi M, Baldessari D, Pozzi S, et al · · 2023 · cited 1× · PMID 37601533 · DOI 10.3389/frma.2023.1067981
Oxidative Stress: Molecular Mechanisms, Diseases, and Therapeutic Targets.
Qin Y, Qian C, Li W, Wang Q, et al · · 2026 · PMID 41624249 · DOI 10.1002/mco2.70600
Does Amyotrophic Lateral Sclerosis (ALS) Have Metabolic Causes from Human Evolution?
Spedding M. · · 2025 · PMID 41227379 · DOI 10.3390/cells14211734

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Other The University of Queensland trials

Trials by the same sponsor.

NCT06120673 — REmission in Membranous Nephropathy International Trial (REMIT) · Phase 3 · withdrawn
NCT06642597 — STarting incrEmental Prescription of Peritoneal Dialysis · NA · recruiting
NCT07114354 — Enhancing Utility of Neuropsychological Evaluation for Earlier and Effective Diagnosis of Dementia in Parkinson's Diseas · NA · not yet recruiting
NCT06806709 — Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial) · NA · recruiting
NCT06882239 — SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonom · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04788745 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Queensland
Last refreshed: 20 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04788745.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing