A Study of Fisetin to Treat Carpal Tunnel Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter C. Amadio, M.D.

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.