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A Study of Fisetin to Treat Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fisetin
Sponsored by
Peter C. Amadio, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult men and post-menopausal women between age 45 and 80.
  • 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.
  • Able to complete English-language questionnaires and clinical evaluations.

Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • 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.
  • Currently take a steroid medication either regularly or on as needed basis.
  • Currently taking warfarin (medication can be safely held during the following times):
  • Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
  • Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30).
  • Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases).
  • Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period then they will be removed from the study primarily due to risk of drug-drug interaction.

  • Any of the following clinical diagnoses or conditions:

    • Cervical radiculopathy;
    • Renal failure (see below);
    • Liver disease (see below);
    • Taking warfarin;
    • Peripheral nerve disease;
    • Uncontrolled diabetes (see below); or
    • Other metabolic disorder (as per clinical judgement).

  • The following laboratory tests as indicated or as per clinical judgement:

    • Fasting plasma glucose > 200 as a marker of poor diabetic control;
    • CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease;
    • AST > 100 as a marker of liver disease;
    • Bilirubin > 2.0 as a marker of liver disease;
    • Cystatin c > 3 as a marker of advanced kidney disease;
    • A1c > 8 as a marker of poor diabetic control;
    • CRP > 10 as a marker of systemic inflammation;
    • ESR > 25 as a marker of systemic inflammation.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Women of child-bearing potential.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carpal Tunnel Syndrome

Arm Description

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

Outcomes

Primary Outcome Measures

Change in CTS symptoms
Measured using the self-reported Boston Carpal Tunnel Syndrome questionnaire (BCTQ) score to assess symptoms severity and overall function of subjects with CTS. Questionnaire consist of 11 questions for symptoms severity and 8 questions for function on a 1-5 point scale for each question; higher scores indicate greater severity and dysfunction.

Secondary Outcome Measures

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
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

Full Information

First Posted
May 22, 2022
Last Updated
October 25, 2022
Sponsor
Peter C. Amadio, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05416515
Brief Title
A Study of Fisetin to Treat Carpal Tunnel Syndrome
Official Title
Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter C. Amadio, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carpal Tunnel Syndrome
Arm Type
Experimental
Arm Description
Adult men and post-menopausal women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months
Intervention Type
Drug
Intervention Name(s)
Fisetin
Intervention Description
100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Primary Outcome Measure Information:
Title
Change in CTS symptoms
Description
Measured using the self-reported Boston Carpal Tunnel Syndrome questionnaire (BCTQ) score to assess symptoms severity and overall function of subjects with CTS. Questionnaire consist of 11 questions for symptoms severity and 8 questions for function on a 1-5 point scale for each question; higher scores indicate greater severity and dysfunction.
Time Frame
Baseline, 60 days
Secondary Outcome Measure Information:
Title
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
Description
Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence
Time Frame
Baseline, 60 days
Title
percent decrease in blood markers of cellular senescence in long-term
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
Time Frame
Baseline, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult men and post-menopausal women between age 45 and 80. 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. Able to complete English-language questionnaires and clinical evaluations. Exclusion Criteria: Unable or unwilling to give informed consent. 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. Currently take a steroid medication either regularly or on as needed basis. Currently taking warfarin (medication can be safely held during the following times): Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1); Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30). Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases). Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period then they will be removed from the study primarily due to risk of drug-drug interaction. Any of the following clinical diagnoses or conditions: Cervical radiculopathy; Renal failure (see below); Liver disease (see below); Taking warfarin; Peripheral nerve disease; Uncontrolled diabetes (see below); or Other metabolic disorder (as per clinical judgement). The following laboratory tests as indicated or as per clinical judgement: Fasting plasma glucose > 200 as a marker of poor diabetic control; CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease; AST > 100 as a marker of liver disease; Bilirubin > 2.0 as a marker of liver disease; Cystatin c > 3 as a marker of advanced kidney disease; A1c > 8 as a marker of poor diabetic control; CRP > 10 as a marker of systemic inflammation; ESR > 25 as a marker of systemic inflammation. Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia. Women of child-bearing potential.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Amadio
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Amadio, MD
Phone
507-284-2806
Email
pamadio@mayo.edu
First Name & Middle Initial & Last Name & Degree
Paul Cox
Phone
507-293-6470
Email
cox.paul@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Fisetin to Treat Carpal Tunnel Syndrome

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