RECRUITING

4-AP Peripheral Nerve Crossover Trial

Conditions

Peripheral Nerve Injury Crush Injury 4 aminopyridine peripheral nerve

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the role of single dose 4-aminopyridine (4-AP) on the diagnosis of severing vs non-severing nerve injury after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after peripheral nerve traction and/or crush injuries allowing the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment. Participants will be randomized to one of two groups to determine the order of treatment they receive (drug and placebo vs placebo and drug). Participants will undergo baseline testing for nerve assessment, receive either drug or placebo based on randomization and undergo hourly sensory and motor evaluation, EDX testing and serum 4AP levels for three hours after dosing. Participants will then repeat this with the crossover arm.

Official Title

Pharmaco-Diagnostic Crossover Trial for Peripheral Nerve Continuity After Trauma

Quick Facts

Study Start:2025-03-01

Study Completion:2028-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06003166

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.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * Able to complete single day dosing within seven days (168 hours) of nerve injury diagnosis. * 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. * Capable of safely undergoing electrodiagnostic testing (EDX). * Availability for all testing days and main trial day.	* Not able to complete dosing within seven days (168 hours) of nerve injury diagnosis * 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.

Inclusion Criteria

Exclusion 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.
* Able to complete single day dosing within seven days (168 hours) of nerve injury diagnosis.
* 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.
* Capable of safely undergoing electrodiagnostic testing (EDX).
* Availability for all testing days and main trial day.

* Not able to complete dosing within seven days (168 hours) of nerve injury diagnosis
* 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.

Contacts and Locations

Study Contact

Andrea Horne

CONTACT

520-626-6456

ahh@arizona.edu

Principal Investigator

John Elfar, MD

PRINCIPAL_INVESTIGATOR

University of Arizona

Study Locations (Sites)

Banner University Medical Center

Tucson, Arizona, 85724

United States

Collaborators and Investigators

Sponsor: University of Arizona

John Elfar, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-03-01

Study Completion Date2028-07-31

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

4 aminopyridine
peripheral nerve
crush injury

Additional Relevant MeSH Terms

Peripheral Nerve Injury
Crush Injury