Plain-English translation of NCT05650229 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
The FALCON study is testing whether a medication called can help reduce fatigue and improve physical abilities in adults living with primary mitochondrial disease. Half of participants will receive this medication, while the other half will receive a placebo (a pill with no active ingredient), and neither participants nor the research team will know who receives which treatment. The study will last about 61 to 65 weeks total, including a screening phase, 48 weeks of treatment, and a follow-up safety period.
Fatigue and muscle weakness are major problems for people with mitochondrial disease, and there are currently limited treatment options. This trial aims to determine whether this medication can safely and effectively help reduce these debilitating symptoms.
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You would first go through a screening phase lasting 8 to 12 weeks, where the research team confirms your diagnosis and checks that you qualify for the study. If accepted, you will be randomly assigned to take either the new medication or a placebo twice daily for 48 weeks, then have a 5-week safety follow-up period. During the study, you will visit the clinic for check-ups, take a physical test (like a sit-to-stand test), report your fatigue levels, and complete electronic surveys to track how you're doing.
AI-generated summary from trial data · Aug 28, 2026 · Not medical advice
United States