NCT06003166 4-AP Peripheral Nerve Crossover Trial
| NCT ID | NCT06003166 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arizona |
| Condition | Peripheral Nerve Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2025-04-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
John Elfar, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT06003166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Peripheral Nerve Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06003166 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06003166 currently recruiting?
Yes, NCT06003166 is actively recruiting participants. Contact the research team at ahh@arizona.edu for enrollment information.
Where is the NCT06003166 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT06003166 clinical trial?
NCT06003166 is sponsored by University of Arizona. The principal investigator is John Elfar, MD at University of Arizona. The trial plans to enroll 68 participants.