Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/28/23. Questions regarding updates should be directed to the study team contact.