Pharmaco-Diagnostic Crossover Trial for Peripheral Nerve Continuity After Trauma

What this Trial Is About

Researchers are evaluating the role of a single dose of 4-aminopyridine (4-AP) to help diagnose whether nerve injuries from peripheral nerve traction or crush are complete or incomplete. The study aims to speed up the identification of nerve continuity compared to standard electrodiagnostic and clinical assessments. This is a phase 2, randomized, double-blind crossover trial conducted at a single center. Participants will be randomized to receive either a 10 mg dose of 4-aminopyridine followed by a placebo, or placebo followed by the drug, with the order determined randomly. Each participant undergoes baseline sensory and motor testing, blood sampling, and then hourly testing for three hours after each dose to assess sensory and motor function, electrodiagnostic results, and serum 4-AP levels. After completing both treatment arms, testing concludes. Following initial testing, participants will be monitored for 20 weeks with follow-up visits at 2, 6, 12, 18, and 20 weeks, including physical exams and phone interviews at 9 and 15 weeks to assess subjective motor and sensory function. The main outcome measured is the subjective return of sensation during dosing and at various post-injury time points. Each visit or call lasts about 30 minutes.

4-AP Peripheral Nerve Crossover Trial