4AP to Delay Carpal Tunnel Release (CTR)

Launched by JOHN ELFAR · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called 4-aminopyridine, which is already approved by the FDA, to see if it can help delay the need for surgery in people with carpal tunnel syndrome. Carpal tunnel syndrome is a condition where pressure on a nerve in the wrist causes pain and numbness in the hand. The goal of this trial is to find out if taking this medication can help patients manage their symptoms and possibly avoid surgery for a while.

To be eligible for the trial, participants need to be adults aged 18 to 90 who have been diagnosed with carpal tunnel syndrome without other nerve issues. They should also be able to perform some simple tests to check their nerve function and commit to taking the medication twice a day for six weeks. While the trial is not yet recruiting participants, those who join can expect regular check-ins and tests to monitor their progress. It's important for potential participants to understand that they should not have certain medical histories, such as neurological disorders or severe kidney problems, to qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with non-traumatic carpal tunnel syndrome without any other confounding diagnosis (e.g. cubital tunnel syndrome, cervical nerve compression)
• • Standard of care EDX testing within 6 months of study enrollment
• • Cognitive ability to report sensory and motor deficit during examination.
• • Able to complete twice daily dosing of 4-AP for the entire 6 week treatment period.
• • Adults subject aged 18-90
• • Ability to give written informed consent.
• • Capable of safely undergoing electrodiagnostic testing (EDX).
• • Availability for all study visits.
• Exclusion Criteria:
• • Inability to complete twice daily dosing during 6 week treatment period.
• • History of multiple sclerosis, stroke or any other diagnosed neurological disorder
• • History of hypersensitivity to AMPYRA® or 4-aminopyridine
• • Current use of aminopyridine medications, including other compounded 4-AP
• • Suspected renal impairment based on the Choyke questionnaire.