Carpal Tunnel Syndrome
Conditions
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, 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.
Interventions
DRUGFisetin
100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Sponsors
Peter C. Amadio, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment: Inclusion Criteria: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Boston Carpal Tunnel Syndrome (BCTQ) Score | Baseline, 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence |
| Percent Decrease in Blood Markers of Cellular Senescence in Long-term | Baseline, 180 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carpal Tunnel Syndrome Adult men and women who had a clinical diagnosis for Carpal Tunnel Syndrome (CTS) received Fisetin for 2-day periods for 2 months.
Fisetin: 100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Carpal Tunnel Syndrome |
|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 14.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 15 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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.
Time frame: Baseline, 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carpal Tunnel Syndrome | Change in Boston Carpal Tunnel Syndrome (BCTQ) Score | -0.5 score on a scale | Standard Deviation 0.6 |
Secondary
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
Time frame: Baseline, 60 days
Secondary
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
Time frame: Baseline, 180 days