A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: 4-Aminopyridine

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.

• Able to complete dosing within four days (96 hours) of nerve injury diagnosis.

• Able to provide informed consent

• 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.

Exclusion Criteria:

• Not able to complete dosing within four days (96 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

• 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.

• Pregnancy, breastfeeding or incarcerated individuals.

• Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, eg. Cimetidine.