Status:
COMPLETED
A Study of Fisetin to Treat Carpal Tunnel Syndrome
Lead Sponsor:
Peter C. Amadio, M.D.
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief 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, usin...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment:
- Males and females between age 21 and 80 years of age.
- Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long, or radial border of ring finger.
- Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
- A clinical diagnosis of carpal tunnel syndrome. Patients with bilateral CTS will have the more severe hand enrolled.
- Able to complete English-language questionnaires and clinical evaluations.
- Willingness to avoid pregnancy.
- Female participants of childbearing potential must have a negative pregnancy test at screening (serum) and before the first dose on Day 1 (urine), before the third dose on Day 29 (urine), and 60 days after the final dose on day 60 (urine).
- Sexually active female participants of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening until 30 days after the last dose of study drug (day 60). Permitted methods in preventing pregnancy (see Appendix A) will be communicated to the participants and their compliance confirmed.
- All female participants of childbearing potential will refrain from donating oocytes from screening-day 60 of the study.
- Women without child bearing potential (ie., surgically sterile with hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without the above precautions.
- Willing and able to comply with study procedures and requirements and attend all study visits as defined in this protocol.
- Exclusion Criteria
- Subjects with any of the following exclusion criteria will not be eligible for enrollment:
- General
Exclusion
- Unable or unwilling to give informed consent.
- Pregnant or breast feeding
- Previous carpal tunnel release on the study hand
- History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
- Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
- Laboratory
Key Trial Info
Start Date :
October 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05416515
Start Date
October 9 2022
End Date
January 24 2025
Last Update
December 24 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905