Ensayos clínicos

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 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 (i.e.., surgically sterile with hysterectomy and/or bilateral oophorectomy 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:

• 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.

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

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.