4AP for Carpal Tunnel Syndrome (CTS)

John Elfar

Status and phase: Begins enrollment in 8 months; Phase 2

Conditions: Compression Neuropathy; Carpal Tunnel Syndrome

Treatments: Drug: 4-Aminopyridine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06294821

00003845

Details and patient eligibility

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.

Full description

Carpal tunnel syndrome affects somewhere between 3 and 10% of the Unites States population. Symptoms associated with this disorder include numbness and tingling in the radial three digits of the hand. These symptoms often cause sleeplessness. They have been attributed to work related activities. The diagnosis of carpal tunnel syndrome is made clinically. Several confirmatory tests exist in the setting of carpal tunnel syndrome. In the United States the gold standard diagnostic for carpal tunnel syndrome is electrodiagnostic evaluation. This notwithstanding, recent literature suggests that other diagnostic methods including ultrasound evaluation of the median nerve at the carpal tunnel as well as clinical diagnostic criteria are sufficient to adequately and specifically diagnose carpal tunnel syndrome.

Several treatments exist for carpal tunnel syndrome. Treatment range from non-operative braces or positional movements. Moving on to intervention treatments there are several injections that have been used to treat carpal tunnel syndrome. Carpal Tunnel Syndrome is most definitively and completely treated by surgical release of the median nerve at the carpal tunnel. Surgical releases themselves have been performed under a variety of techniques from formal median nerve exploration to mini-open release as well endoscopic release. Resolution of symptoms after carpal tunnel release has been regarded as the gold standard to which other treatments can be compared.

Several registries of compression neuropathy patients have been compiled. These registries reveal that non-invasive assessment with standardize validated questionnaires can be used to measure the progression of symptomology, and the resolution of treatment. Given the history and wealth of experience in the diagnosis and treatment in this condition, it's natural to ask are there non-operative pharmacological treatments that may delay or remove the need for carpal tunnel release surgery. Certainly, the comparison to surgical decompression as the gold standard is desirable.

More research is needed to evaluate the role of 4-aminopyridine (4AP) in the treatment of compression neuropathy. The investigational treatment will be used to test the hypothesis that 4AP improves symptoms and electrodiagnostic parameters in carpal tunnel syndrome patients.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

4-aminopyridine

Active Comparator group

Description:

Study drug: dalfampridine (generic) 10mg ER capsule

Treatment:

Drug: 4-Aminopyridine

Placebo

Placebo Comparator group

Description:

Placebo-1 capsule

Treatment:

Other: Placebo