A Study of Fisetin to Treat Carpal Tunnel Syndrome

NCT05416515 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 21-010406
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (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.

  Baseline, 60 days

Secondary Outcomes (2)

• 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

  Baseline, 60 days

• Percent Decrease in Blood Markers of Cellular Senescence in Long-term

  Baseline, 180 days

Study Arms (1)

Carpal Tunnel Syndrome

EXPERIMENTAL

Adult men and women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months

Drug: Fisetin

Interventions

Fisetin DRUG

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

Carpal Tunnel Syndrome

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgement
• Human immunodeficiency virus infection
• Known active hepatitis B or C infection

Sponsors & Collaborators

• Peter C. Amadio, M.D.: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

fisetin

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Peter Amadio, M.D.
• Organization: Mayo Clinic

pamadio@mayo.edu

507-538-1296

Study Officials

• Peter C Amadio, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 13, 2022
• Study Start: October 9, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 24, 2025
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Locations

US (1)