4-aminopyridine for Skin Wound Healing

NCT06333171 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 00003872
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults. The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing. The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.

Conditions

Wounds; Wound of Skin; Wound Heal; Wounds and Injuries

Keywords

4 aminopyridine; wound healing

Outcome Measures

Primary Outcomes (1)

• Return of skin integrity and wound closure after skin punch biopsy

  Axillary skin punch biopsies will be performed on healthy volunteers. Wound healing will be measured using visual assessment.

  6 weeks

Secondary Outcomes (1)

• The effect of 4-AP on the hair number and growth at the skin punch biopsy site.

  6 weeks

Study Arms (2)

Group A: 4-aminopyridine

ACTIVE COMPARATOR

dalfampridine (generic) 10 mg capsule po every 12 hours

Drug: 4-Aminopyridine

Group B: Placebo

PLACEBO COMPARATOR

Placebo-1 capsule po every 12 hours

Other: Placebo

Interventions

4-Aminopyridine DRUG

Active study drug

Also known as: 4AP, dalfampridine

Group A: 4-aminopyridine

Placebo OTHER

Placebo comparator

Group B: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy adult patients without skin conditions effecting the skin of the axilla or upper inner arm.
• Cognitive ability to evaluate wound healing, report sensory and motor deficit during examination.
• Eligible for standard of care plan for wound closure by secondary intention (normal healing without intervention).
• Adults subject aged 18-70
• Ability to give written informed consent.
• Capable of safely coming in for follow up visits on all scheduled appointments.

You may not qualify if:

• History of multiple sclerosis, stroke or any other diagnosed neurological disorder
• History of hypersensitivity to AMPYRA® or 4-aminopyridine
• Current use of aminopyridine medications, including other compounded 4-AP
• Suspected renal impairment based on the Choyke questionnaire.
• History of difficult compliance with timely follow up
• Patients outside the age range
• Unable to provide informed consent.
• Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
• Patients with a concomitant traumatic brain injury.
• Patients unable to communicate.
• Patients unwilling to complete the study requirements.
• Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.
• Pregnancy, breastfeeding or incarcerated individuals.
• Non-English speaking
• Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds

Sponsors & Collaborators

• John Elfar: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John Elfar, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Horne

CONTACT

520-626-6456; ahh@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tenured Professor, Chairman, Department of Orthopaedic Surgery

Model Details: This is a double-blind, randomized, placebo-controlled trial design.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)