4-AP Peripheral Nerve Crossover Trial

Conditions

• Crush Injury
• Peripheral Nerve Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 4-Aminopyridine — DRUG
  Study drug will be a one time, 10mg dose of 4-aminopyridine
• Placebo — OTHER
  Matched placebo

Study Details

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.

Key Dates

Start date

Apr 21, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2027

Completion

Jul 31, 2028

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Experimental: 4AP then placebo (Group A)
  Subjects randomized to this group will receive the study drug (4AP) followed by the placebo.
• Experimental: Placebo then 4AP (Group B)
  Subjects randomized to this group will receive the placebo first followed by the study drug (4AP)

Primary Outcome Measure

Subjective return of sensation [ Time Frame: During dosing of drug intervention and 2, 6, 9, 12, 15, 20 weeks post injury ]

Central Contacts

• Andrea Horne
  520-626-6456
  [email protected]

Locations (1)

Find similar trials in Tucson, AZ

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