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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Nerve Injury

In brief

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.

Key facts

Study ID

NCT04026568

Run by

Milton S. Hershey Medical Center

People needed

1

Starts

2021-08-17

Expected to finish

2022-07-18

Last updated by the study team

2022-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MS Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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