4AP for Carpal Tunnel Syndrome (CTS) (CTS)

January 22, 2026 updated by: John Elfar

4-Aminopyridine to Delay Carpal Tunnel Release or Resolve Carpal Tunnel Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: John Elfar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4-aminopyridine
Study drug: dalfampridine (generic) 10mg ER capsule
Drug: 4-Aminopyridine
Subjects will receive either the active study drug (4-aminopyridine) or placebo to determine the effects of 4AP on carpal tunnel syndrome
Other Names:
  • 4AP
Placebo Comparator: Placebo
Placebo-1 capsule
Other: Placebo
Subjects will receive either the active study drug (4-aminopyridine) or placebo to determine the effects of 4AP on carpal tunnel syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Time Frame: Baseline (prior to study treatment) to 56 weeks post treatment
Improvement of Carpal Tunnel Syndrome symptoms will be measured using the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) - a validated patient reported outcome measure. The scale contains 6 items on the severity and frequency of night and daytime numbness, tingling and pain. Each item is scored on a 5-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Subjects will complete a baseline questionnaire prior to treatment initiation. The questionnaire will be completed all study visit following initiation of treatment until the final study visit at 56 weeks post treatment.
Baseline (prior to study treatment) to 56 weeks post treatment
Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: Baseline (prior to study treatment) to 56 weeks post treatment.
Improvement of Carpal Tunnel Syndrome symptoms will be measured with standardized validated outcomes measure, the Michigan Hand Outcomes Questionnaire (MHQ) for improvement in carpal tunnel symptomatology. The MHQ is a tool used to assess patients with hand disorders through the measurement of 6 health domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. Baseline measures will be completed prior to treatment and repeated at each study visit with the final outcome questionnaire completed at the final, 56 week visit.
Baseline (prior to study treatment) to 56 weeks post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrodiagnostic improvement following treatment
Time Frame: Baseline (prior to study treatment) and 8 weeks post treatment.
Nerve conduction velocity improvement > 10% compared to pre-treatment nerve conduction velocity. Electrodiagnostic studies will be completed as part of standard of care prior to initiation of treatment and repeated at 8 weeks post treatment.
Baseline (prior to study treatment) and 8 weeks post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Elfar

Investigators

  • Principal Investigator: John Elfar, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00003845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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