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Peripheral Nerve InjuryDiagnostics and screeningDrugPhase 2

What this study is

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.

What's being tested

  • 4-Aminopyridine

    Intervention · DRUG

    Study drug will be a one time, 10mg dose of 4-aminopyridine

  • Placebo

    Intervention · OTHER

    Matched placebo

Study details

Official title
Pharmaco-Diagnostic Crossover Trial for Peripheral Nerve Continuity After Trauma
Sponsor
University of Arizona
Conditions
Peripheral Nerve Injury · Crush Injury
Enrolling
68 people
Starts
2025-04-21
Est. completion
2028-07-31
Design
Quadruple-blind, randomized, crossover, Phase 2
Record
View on ClinicalTrials.gov ↗