Status:
TERMINATED
A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Nerve Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
This proposal contains two distinct aims to be investigated in two similar but distinct groups of patients. Aim 1: To examine the mechanistic effect of 4AP on the return of sensorimotor function and ...
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.
- 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
- 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.
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04026568
Start Date
August 17 2021
End Date
July 18 2022
Last Update
October 18 2022
Active Locations (1)
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1
MS Hershey Medical Center
Hershey, Pennsylvania, United States, 17033