Evaluating 4-aminopyridine for nerve injury diagnosis
Pharmaco-Diagnostic Crossover Trial for Peripheral Nerve Continuity After Trauma
This study is testing if a single dose of 4-aminopyridine can help doctors better diagnose the severity of nerve injuries in people.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06003166 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a single dose of 4-aminopyridine (4-AP) in diagnosing the severity of peripheral nerve injuries, specifically distinguishing between severing and non-severing injuries. Participants will be randomized into two groups to receive either the drug or a placebo, followed by a crossover to the alternate treatment. The study will involve comprehensive sensory and motor evaluations, electrodiagnostic testing, and serum level assessments of 4-AP over a three-hour period. The goal is to determine if 4-AP can expedite the identification of incomplete nerve injuries compared to standard diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with unclear continuity of peripheral nerves due to trauma affecting two or fewer limbs.
Not a fit: Patients with distracting injuries or those scheduled for surgical exploration of the nerve within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of peripheral nerve injuries, improving patient outcomes.
How similar studies have performed: While the use of 4-AP in this context is novel, similar studies have shown promise in enhancing nerve injury assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with trauma involving two or less limbs where the continuity of a given peripheral nerve or nerves is unclear on presenting physical examination. * Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve. * Cognitive ability to report sensory and motor deficit during examination. * Eligible for standard of care plan of monitoring vs surgical exploration of the nerve. * Adults subject aged 18-90 * Known limb trauma which resulted in nerve injury (aim 1) or post-operative/post intervention nerve injury (aim 2). * Ability to give written informed consent. * Availability for all testing days and main trial day. Exclusion Criteria: * Distracting injury which prevents adequate examination. * Plan for surgical exploration of the nerve during the ensuing 48 hours. * Plan for surgical exploration of the nerve as part of another surgical procedure within 48 hours of evaluation. * Intoxication during examination or evidence of cognitive deficit that emerges during examination. * 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 * Renal impairment based on calculated GFR (GFR\<80 mL/min). This laboratory value is measured in all inpatient trauma patients as part of the standard of care. * History of difficult compliance with timely follow up or plan to seek care at another institution closer to home. * Patients outside the age range or unable to consent. * Patients with a known history of a seizure disorder (4AP overdose can, in selected cases, result in limited seizure activity). * Patients with a concomitant traumatic brain injury. * Patients unable to communicate return or loss of sensation. * Patients unable to exhibit motor control on the affected limb at baseline. * Patients unwilling to complete the study requirements. * Patients with injuries too extensive to isolate a single nerve(s) for testing. * Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine. * Pregnancy, breastfeeding or incarcerated individuals.
Where this trial is running
Tucson, Arizona
- Banner University Medical Center — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: John Elfar, MD — University of Arizona
- Study coordinator: Andrea Horne
- Email: ahh@arizona.edu
- Phone: 520-626-6456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.