Status:
RECRUITING
4-AP Peripheral Nerve Crossover Trial
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Peripheral Nerve Injury
Crush Injury
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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. T...
Detailed Description
This is a single-center study that will be conducted at the University of Arizona College of Medicine, Tucson. It is a double-blind, randomized, crossover trial design. Group A will receive the study ...
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.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06003166
Start Date
April 21 2025
End Date
July 31 2028
Last Update
August 5 2025
Active Locations (1)
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1
Banner University Medical Center
Tucson, Arizona, United States, 85724