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Carpal Tunnel SyndromePhase 2NCT05416515

A Study of Fisetin to Treat Carpal Tunnel Syndrome

A Phase 2 study testing Fisetin in people with Carpal Tunnel Syndrome, run by Peter C. Amadio, M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Fisetin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
9 Oct 2022to 24 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Subjects with any of the following exclusion criteria will not be eligible for enrollment:
  • General Exclusion Criteria:
  • 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.
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  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Laboratory Exclusion Criteria:
  • The following laboratory tests as indicated or as per clinical judgement:
  • Bilirubin > 2.0; serum aspartate transaminase (AST) > 4 X upper limit of normal, or alanine aminotransferase (ALT) > 4 X upper limit of normal as a marker of liver disease
  • Hemoglobin < 7g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤40,000/μL (≤40 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening as a marker of poor nutrition
  • Plasma and/or serum fasting glucose > 300 or HbA1c > 9 as a marker of poor diabetic control
  • Creatinine >2.5, cystatin c >3 or eGFR< 25 ml/min/1.73 m2 as a marker of advanced kidney disease,
  • CRP > 10 or ESR >25 as a marker of systemic inflammation
  • Unstable (as per clinical judgement) major cardiovascular, renal, endocrine, immunological, or hepatic disorder
  • Clinical History Exclusion Criteria
  • History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgement
  • Any of the following clinical diagnosis or conditions: cervical radiculopathy, renal failure (see laboratory exclusion criteria), liver disease (see laboratory exclusion criteria), peripheral nerve disease, uncontrolled diabetes (see laboratory exclusion criteria), or other metabolic disorder; as per clinical judgement
  • Human immunodeficiency virus infection
  • Known active hepatitis B or C infection
  • Invasive fungal infection
  • Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites
  • New/active invasive cancer except non-melanoma skin cancers
  • Medication Exclusion Criteria
  • Known hypersensitivity or allergy to Fisetin or other flavonoids
  • Currently participating in another study using Fisetin or currently taking any flavonoid as a nutritional supplement. Note that consuming foods rich in flavonoids is NOT an exclusion, both because flavonoids are present in almost all fruits and vegetables, making such an exclusion impossible as a practical matter, and, from a scientific perspective, the amount of flavonoids in general, and Fisetin in particular, present in foods is far lower than the dose that will be administered in the trial.
  • Patients currently taking medications listed in the Investigator Brochure are excluded unless medication can be safely held following the guidelines in the Investigator Brochure.
  • If the patient is required to initiate any medication listed in the Investigator Brochure during the study, the PI will reassess their continued participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Fisetin
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FisetinDrug

    100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days

Study groups in NCT05416515
Study groupRoleWhat they receive
Carpal Tunnel SyndromeExperimentalAdult men and women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months
Receives: Drug: Fisetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Boston Carpal Tunnel Syndrome (BCTQ) Score

    The Boston Carpal Tunnel Syndrome questionnaire (BCTQ) assesses symptom severity and overall function of subjects with Carpel Tunnel Syndrome. The questionnaire consists of two sections: 1. Symptom Severity (11 questions) and 2. Functional Status (8 questions). Subjects are asked to rate each question on a scale of 1 to 5. The mean score for each section is calculated by summing the individual question responses and diving by the number of questions resulting in a total score ranging from 1 to 5, with higher scores indicating greater symptom severity and dysfunction.

    Measured: Baseline, 60 days

Secondary outcomes (2)

  1. Percent Decrease in Blood Markers of Cellular Senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and Additional Exploratory, Novel Assays

    Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence

    Measured: Baseline, 60 days

  2. Percent Decrease in Blood Markers of Cellular Senescence in Long-term

    percent decrease in blood markers of cellular senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and additional exploratory, novel assays

    Measured: Baseline, 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start9 Oct 2022
  3. Primary completion31 Dec 2024
  4. Study completion24 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416515
Sponsor's protocol ID
21-010406
Status last verified
Dec 2025
First submitted
22 May 2022
Last updated
24 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fisetin in people with Carpal Tunnel Syndrome, run by Peter C. Amadio, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Boston Carpal Tunnel Syndrome (BCTQ) Score (time frame: Baseline, 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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