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NCT06003166 · ClinicalTrials.gov registry record · Phase 2
4-AP Peripheral Nerve Crossover Trial
A Phase 2 study of Peripheral Nerve Injury and Crush Injury, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT06003166: Recruiting Phase 2 study of Peripheral Nerve Injury and Crush Injury, sponsored by University of Arizona.
NCT06003166 is a Phase 2 study of Peripheral Nerve Injury and Crush Injury that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 68 participants, above the 20-participant average among 3 other Peripheral Nerve Injury trials with a reported enrollment target (240% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06003166, a Phase 2 study of Peripheral Nerve Injury and Crush Injury, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Return of lost sensation after nerve injury attributable to circulating 4AP. Subjective return of sensation in the injured limb or portion of the limb. Patients for this trial are not able to sense in portions of their limbs. The measure will be sensation, measured on the binary scale of yes or no (able to feel the extremity versus unable to feel). This is assessed through clinical examination of the injured limb.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG 4-Aminopyridine
Study Locations (1)
Arizona
- Banner University Medical Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2025-04-21 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT06003166 shows while recruiting
NCT06003166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 20-participant average among 3 other Peripheral Nerve Injury trials with a reported enrollment target (240% higher).
The record links to 2 conditions, with Peripheral Nerve Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06003166 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06003166 about?
NCT06003166 is a clinical study titled "4-AP Peripheral Nerve Crossover Trial". 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 ...
What is the current status of trial NCT06003166?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2025-04-21. Estimated completion is 2028-07-31.
What conditions does trial NCT06003166 study?
This clinical trial studies the following conditions: Peripheral Nerve Injury, Crush Injury.
What interventions are being tested in trial NCT06003166?
The interventions under investigation include: Placebo (OTHER), 4-Aminopyridine (DRUG).
Who is sponsoring clinical trial NCT06003166?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06003166 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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