NCT06003166 is a Phase 2 clinical trial of 4-Aminopyridine in Peripheral Nerve Injury, sponsored by University of Arizona.

Who is sponsoring NCT06003166?

NCT06003166 is sponsored by University of Arizona.

What drugs are being tested in NCT06003166?

Interventions in NCT06003166: 4-Aminopyridine, Placebo.

What condition does NCT06003166 study?

NCT06003166 studies Peripheral Nerve Injury, Crush Injury.

Is NCT06003166 still recruiting?

NCT06003166 is currently recruiting now. Last updated 5 August 2025.

Last reviewed 2025-08-05 · How we verify

NCT06003166

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

4-AP Peripheral Nerve Crossover Trial

Recruiting now Phase 2 Last updated 5 August 2025

What this trial tests

Phase 2 trial testing 4-Aminopyridine in Peripheral Nerve Injury in 68 participants. Currently enrolling.

Timeline

21 April 2025

Primary endpoint
31 December 2027

31 July 2028

Quick facts

Lead sponsor	University of Arizona
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	diagnostic
Enrollment	68
Start date	21 April 2025
Primary completion	31 December 2027
Estimated completion	31 July 2028
Sites	1 location across United States

Drugs / interventions tested

4-Aminopyridine — full drug profile →
Placebo

Conditions studied

Peripheral Nerve Injury — all drugs for Peripheral Nerve Injury →
Crush Injury — all drugs for Crush Injury →

Sponsor

University of Arizona

Who can join

Adults 18 to 90, any sex, with Peripheral Nerve Injury or Crush Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of 4-Aminopyridine

Trials testing the same drug.

NCT04026568 — A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma · Phase 2, PHASE3 · terminated
NCT01543750 — 4-Aminopyridine in Episodic Ataxia Type 2 · Phase 2 · withdrawn

Other recruiting trials for Peripheral Nerve Injury

Currently open trials in the same condition.

NCT05541250 — Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI) · Phase 1 · recruiting
NCT02359825 — Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function · Phase 1 · recruiting

Other University of Arizona trials

Trials by the same sponsor.

NCT04062890 — Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance · Phase 2 · withdrawn
NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain · NA · not yet recruiting
NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy · suspended
NCT06567899 — Mechanistic Underpinnings of Preeclampsia · not yet recruiting
NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06003166 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Arizona
Last refreshed: 5 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06003166.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing