The main criteria for participation
The FALCON trial is recruiting 180 adults in several countries around the world, including France, suffering from mitochondrial disease due to an abnormality in mitochondrial DNA, and who present in particular with chronic fatigue linked to their pathology and muscular symptoms (myopathy, difficulty climbing slopes and stairs).
The objective
FALCON aims to evaluate the efficacy, compared to a placebo, of taking one KL 1333 tablet twice daily on symptoms of fatigue, daily living, leg function, and endurance. The safety and tolerability of the treatment will also be assessed.
It’s a double-blind, randomized trial: patients are randomly assigned to the treatment group or the placebo group, and neither the patient nor the medical team knows who is receiving what. This is a common step before being able to offer a treatment to all patients, subject, of course, to its safety and effectiveness.
In practice
The FALCON trial lasts 14 to 16 months, with an initial participant assessment phase of two to three months, followed Par treatment or placebo (for 5 people included, 3 will receive KL 1333 and 2 the placebo) for approximately 11 months, and finally 5 weeks of so-called “safety” follow-up.
The various assessments – fatigue, quality of life, mobility, general condition perceived Par the patient and Par the doctor, etc. – are carried out at the time of inclusion and then at the end of taking the treatment or placebo.
In France, the study is being conducted at the Bordeaux University Hospital (Pellegrin Hospital Group), the Roger Salengro Hospital in Lille, the Nice University Hospital (Pasteur 2 and Archet 2 hospitals) and the Pitié-Salpêtrière Hospital in Paris.
Where are we?
Recruitment is over.