4-Aminopyridine for Burns

Overseen By Andrea Horne

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: John Elfar

Must not be taking: Aminopyridines, OCT2 inhibitors

Disqualifiers: Neurological disorders, Seizure disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called 4-Aminopyridine to determine if it can accelerate burn healing. Researchers aim to assess its effectiveness in improving healing for individuals with second-degree burns, which are serious but do not penetrate the entire skin. Participants will take either a 4-Aminopyridine capsule or a placebo every 12 hours. This trial may suit adults with recent second-degree burns covering a small skin area who can attend regular follow-up appointments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. Specifically, you cannot participate if you are currently using aminopyridine medications or organic cat-ion transporter 2 (OCT2) inhibitors like Cimetidine.

Is there any evidence suggesting that 4-Aminopyridine is likely to be safe for humans?

Research has shown that 4-Aminopyridine (4-AP), also known as dalfampridine, is usually safe at recommended doses. Studies have identified common side effects such as dizziness and urinary tract infections. Reports indicate that higher doses can cause symptoms like shaking and increased nervousness. However, the risk of serious heart problems, such as an irregular heartbeat, remains low at normal doses.

The FDA has already approved this treatment for other uses, such as improving walking in people with multiple sclerosis, indicating its safety when used correctly. Nonetheless, anyone considering joining a clinical trial should discuss potential risks with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for burns focus on wound care and infection prevention, but 4-aminopyridine offers a unique approach by potentially enhancing nerve function and facilitating healing. Unlike standard care options, which often involve topical antibiotics and dressings, 4-aminopyridine is an oral medication that may accelerate recovery by improving cellular communication. Researchers are excited about this treatment because its novel mechanism—blocking potassium channels—could lead to faster and more effective healing than current methods.

What evidence suggests that 4-Aminopyridine might be an effective treatment for burns?

Research has shown that 4-Aminopyridine (4-AP), which participants in this trial may receive, can accelerate burn healing. Studies indicate that 4-AP reduces swelling, aiding in better wound healing. It also reduces inflammation, which is beneficial after a burn. Originally approved for multiple sclerosis, 4-AP has demonstrated an ability to speed up burn wound healing. These findings suggest that 4-AP could be a promising treatment for enhancing burn recovery. ^{2 6 7 8 9}

Who Is on the Research Team?

John Elfar, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for patients who have suffered from traumatic skin burns and are seeking improved healing treatments. The specific eligibility criteria to participate in the trial are not provided.

Inclusion Criteria

I can assess and report on my burn healing and any changes in feeling or movement.

I have burns covering at least 6cm2 of my skin.

I have second-degree burns at most.

Exclusion Criteria

I do not fall within the specified age range for the trial.

I have a history of seizures.

Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-aminopyridine or placebo to evaluate its effect on burn wound healing

12 months

Bi-weekly visits (in-person) for treatment administration and monitoring

Follow-up

Participants are monitored for scar sensitivity, scar formation, and healing rate using POSAS and imaging

12 months

Monthly visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• 4-Aminopyridine
• Placebo

Trial Overview

The study is testing the effects of a drug called 4-Aminopyridine (4-AP) on burn healing, compared to a placebo. It aims to see if 4-AP can speed up and enhance the recovery process for patients with traumatic burns.

How Is the Trial Designed?

Group I: Group A: 4-aminopyridine Active Control 1 Intervention

Dalfampridine (generic) 10 mg capsule PO every 12 hours

Group II: Group B: Placebo Placebo Group 1 Intervention

Placebo - 1 capsule PO every 12 hours

Who Is Running the Clinical Trial?

John Elfar

Lead Sponsor

Trials

4

Recruited

500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11452548/

4-aminopyridine attenuates inflammation and apoptosis and ...

Our data supports a novel therapeutic application of 4-AP in promoting cutaneous burn healing, which is clinically translatable. Results. 4-AP expedited burn ...

2.

nature.com

nature.com/articles/s41420-024-02199-6

4-aminopyridine attenuates inflammation and apoptosis ...

4-AP attenuated inflammation and augmented anti-inflammatory effects following skin burn. We aimed to test 4-AP's effect on post-burn ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06596434

NCT06596434 | 4-Aminopyridine to Treat Skin Burns

Cognitive ability to evaluate burn healing, report sensory and motor deficit during examination. Adults aged 18-80. Ability to give written ...

4.

biorxiv.org

biorxiv.org/content/10.1101/2025.06.05.658142v1.full-text

Topical Delivery of 4-Aminopyridine Enhances Skin ...

Being initially FDA-approved to treat multiple sclerosis, 4-aminopyridine (4-AP) has also been shown to accelerate burn wound closure by ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6241229/

Effectiveness of 4-Aminopyridine for the Management ...

Several trials have independently found 4-AP to have promising but mixed results in reducing spasticity post SCI., Additional studies have also reported ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10538962/

Post-marketing safety surveillance of dalfampridine for ...

The most frequently reported AE signals were urinary tract infection, dizziness, condition aggravated. In addition, 23 AE signals with death ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0149291812001579

The Safety Profile of Dalfampridine Extended Release in ...

A thorough QT study suggested a low risk of induction of QT prolongation and associated cardiac arrhythmias in healthy individuals at therapeutic (10 mg, twice ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3550165/

4-Aminopyridine Toxicity: a Case Report and Review of the ...

4-AP toxicity has been studied in many mammalian species and produces a usual sequence of signs and symptoms: hyperexcitability, salivation, tremors, ...

9.

multiplesclerosisnewstoday.com

multiplesclerosisnewstoday.com/news-posts/dalfampridine-real-world-safety-profile-trials/

Dalfampridine real-world safety profile mostly consistent ...

Common side effects included urinary tract infection (UTI), dizziness and MS worsening, consistent with the therapy's known profile.