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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Arizona
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)