4AP for Carpal Tunnel Syndrome (CTS)
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Compression Neuropathy, Carpal Tunnel Syndrome
In brief
The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can treat carpal tunnel syndrome or delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery.
Key facts
- Study ID
- NCT06294821
- Run by
- John Elfar
- People needed
- 160
- Starts
- 2026-11-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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