NCT05416515

A Study of Fisetin to Treat Carpal Tunnel Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Peter C. Amadio, M.D. · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This research study is being conducted to investigate the safety and effectiveness of the drug Fisetin for mild or moderate carpal tunnel syndrome (CTS).

Detailed description

FITCATS trial will enroll approximately 40 subjects with mild-moderate CTS and evidence of senescence from blood markers into a short term (180 days) prospective phase 2 study of Fisetin therapy, using as outcome measures a well-accepted patient reported outcome questionnaire (Boston CTS questionnaire, BCTQ) as well as reduction from baseline in senescence markers in the blood, including SASP factors and inflammatory markers. Based on the known performance of the BCTQ, the investigators estimate that a sample size of 40 will be sufficient to show a clinically important difference in outcome, if it is present. Each subject will be enrolled for a six-month period. Subjects may withdraw at any time, for any reason.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
DRUG	Fisetin	100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days

Timeline

• Start date: 2022-10-09
• Primary completion: 2024-12-31
• Completion: 2025-01-24
• First posted: 2022-06-13
• Last updated: 2025-12-24
• Results posted: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study