4-Aminopyridine to Treat Skin Burns

NCT06596434 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 00005193
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.

Conditions

Wounds and Injuries; Burns; Second Degree Burn

Keywords

4-aminopyridine; 4-AP; Burns; Second degree burn; Wounds

Outcome Measures

Primary Outcomes (1)

• Healing rate

  Each subject will undergo detailed fiducial-marking augmented macroscopic imaging to determine baseline burn area measurement. These measurements will be repeated at each follow up study visit to assess healing rate.

  12 months

Secondary Outcomes (3)

• Skin-graft rate

  12 months

• Scar formation

  12 months

• Scar sensitivity

  12 months

Study Arms (2)

Group A: 4-aminopyridine

ACTIVE COMPARATOR

Dalfampridine (generic) 10 mg capsule PO every 12 hours

Drug: Drug: 4-Aminopyridine

Group B: Placebo

PLACEBO COMPARATOR

Placebo - 1 capsule PO every 12 hours

Other: Placebo

Interventions

Placebo OTHER

Placebo comparator

Group B: Placebo

Drug: 4-Aminopyridine DRUG

Active study drug

Also known as: 4AP, 4-AP, Dalfampridine

Group A: 4-aminopyridine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Injured (burned) adults with a maximum severity of second-degree burns.
• Burns involving at least 6cm2 of skin area
• Acute burns within 7 days of injury
• Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination.
• Adults aged 18-80
• 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

Burns; 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

Carly J Deal, MPH

CONTACT

520-626-1588; carlyjdeal@arizona.edu

Veronica Rangel, BS

CONTACT

5206264024; vrangel@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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 or 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: August 29, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)