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

200 Participants Needed

Trial Summary

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.

How does the drug 4-Aminopyridine differ from other treatments for burns?

4-Aminopyridine is unique because it is primarily known for its ability to improve nerve function by blocking potassium channels, which is different from typical burn treatments that focus on pain relief and preventing infection. This mechanism might offer a novel approach to managing burns, although its specific effects on burn treatment are not well-documented. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

John Elfar, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of some pharmacological properties of 4-aminopyridine and 3,4-diaminopyridine in vivo. [2019]

2. England pubmed.ncbi.nlm.nih.gov

N-substituted aminohydroxypyridines as potential non-opioid analgesic agents. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Synthesis of 3-(2-pyridyl)-2-substituted-quinazolin-4(3H)-ones as new analgesic and anti-inflammatory agents. [2008]

4. Germany pubmed.ncbi.nlm.nih.gov

Design, synthesis, and biological evaluation of novel 4-phenoxypyridine derivatives as potential antitumor agents. [2019]

5. France pubmed.ncbi.nlm.nih.gov

Synthesis, structural characterization and in vitro antitumor activity of 4-dimethylaminopyridinium (6-chloro-1,1-dioxo-1,4,2-benzodithiazin-3-yl)methanides. [2019]