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4-Aminopyridine for Peripheral Nerve Injury Diagnosis

This study is investigating whether a single 10mg dose of 4-Aminopyridine can help doctors determine if a peripheral nerve (nerves outside the brain and spinal cord) has been completely cut or only crushed after an injury. This could help identify incomplete injuries sooner than standard tests. You might be eligible if you are 18-90 years old, have a peripheral nerve injury involving two or fewer limbs where the nerve's continuity is unclear, and can report your sensations. The main goal is to see if 4-Aminopyridine helps in the subjective (patient-reported) return of sensation, measured at various times up to 20 weeks after injury. The current status of this study is unclear, and it plans to enroll 68 participants.

Study design
This is a double-blind, randomized, crossover study, meaning neither you nor the researchers will know if you're receiving 4-Aminopyridine or a placebo (an inactive substance) first. You will receive both the drug and the placebo at different times. The study plans to enroll 68 participants.
What's involved
You will undergo a thorough baseline sensory and motor evaluation, have an intravenous line placed for blood sampling, and then receive either 4-Aminopyridine or a placebo. Blood samples and sensorimotor examinations will be repeated hourly for three hours. You will also have follow-up assessments for sensation return up to 20 weeks post-injury.
Compensation
Not stated in the trial record.
Follow-up
Your subjective return of sensation will be measured during dosing and at 2, 6, 9, 12, 15, and 20 weeks post-injury.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06003166

4-AP Peripheral Nerve Crossover Trial

Recruiting
PHASE2Ages 18–90InterventionalDiagnostic
University of Arizona
~68 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:4-AminopyridinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subjective return of sensation
Measured over During dosing of drug intervention and 2, 6, 9, 12, 15, 20 weeks post injury

Conditions

Peripheral Nerve Injury
Crush Injury

Explore related trials

Crush InjuryPeripheral Nerve Injury

NCT06003166

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner University Medical Center

    Tucson, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John Elfar, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Andrea Horne
[email protected]
520-626-6456
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Subjective return of sensationDuring dosing of drug intervention and 2, 6, 9, 12, 15, 20 weeks post injury

    Return of lost sensation after nerve injury attributable to circulating 4AP. Subjective return of sensation in the injured limb or portion of the limb. Patients for this trial are not able to sense in portions of their limbs. The measure will be sensation, measured on the binary scale of yes or no (able to feel the extremity versus unable to feel). This is assessed through clinical examination of the injured limb.