Tier 2 — strong

Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS)

Peter C. Amadio
ClinicalTrials.gov trial registry results 2022

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor-investigator: Peter C. Amadio, M.D., Mayo Clinic.
Competing interests
No manuscript-level competing-interest statement is available from the registry results.

Study snapshot

DesignSingle-group open-label Phase 2 interventional study.
ModelAdults aged 21-80 years with mild-to-moderate carpal tunnel syndrome.
Sample40 participants enrolled; study completed in January 2025 and results were posted in December 2025.
InterventionFisetin supplied as 100 mg capsules for two consecutive treatment days, repeated after one month; registry protocol targeted a weight-based senolytic schedule.
DurationParticipants were followed for approximately six months, with primary symptom assessment at 60 days.
EndpointsBoston Carpal Tunnel Syndrome Questionnaire score; Blood p16 and senescence-associated markers; IL-6; IL-15; TNF; PAI-1; ICAM-1; Longer-term senescence-marker follow-up

What the study showed, in plain terms

FITCATS is one of the few completed fisetin studies with results posted to ClinicalTrials.gov. Forty adults with mild-to-moderate carpal tunnel syndrome received fisetin in a single-group Phase 2 study and were followed for symptoms and blood senescence/inflammation markers.

The absence of a placebo or untreated control is the key limitation. Even if symptoms or biomarkers changed over time, the design cannot establish that fisetin caused those changes. The 2026 clinical-translation review therefore treats the results as preliminary rather than confirmatory efficacy evidence.

Key findings

  • The study completed enrollment of 40 participants.
  • Results were posted to ClinicalTrials.gov in December 2025.
  • The trial measured both carpal-tunnel symptoms/function and blood senescence/inflammatory markers.
  • Because there was no control group, changes over time cannot be attributed definitively to fisetin.

What this study can and cannot tell us

  • Single-group open-label design with no placebo or untreated comparator.
  • Registry results are not equivalent to a peer-reviewed results manuscript.
  • Small sample and disease-specific population limit generalizability.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology