4AP for Carpal Tunnel Syndrome (CTS)

About this trial

Last updated 5 months ago

Study ID

00003845

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 90 Years

All Sexes

Trial Timing

Starts in 5 months

What is this trial about?

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.

What are the participation requirements?

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.