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4-Aminopyridine for Burns

Phase 2
Waitlist Available
Led By John Elfar, MD
Research Sponsored by John Elfar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Burns involving at least 6cm2 of skin area
Injured (burned) adults with a maximum severity of second-degree burns
Must not have
Patients outside the age range
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial aims to find a new treatment to help burn injuries heal faster. They will be testing a new agent called 4-AP to see if it can speed up the healing process in patients with

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the exact side effects are not detailed here, 4-Aminopyridine generally has an excellent safety profile. Any potential side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have burns covering at least 6cm2 of my skin.
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I have second-degree burns at most.
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I have burns that occurred within the last week.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not fall within the specified age range for the trial.
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I am unable to understand and give consent for treatment.
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I am willing to follow all study requirements.
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I have a history of neurological disorders like multiple sclerosis or stroke.
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I am currently taking medication that includes OCT2 inhibitors.
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I am currently taking aminopyridine medications.
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I am allergic to AMPYRA® or 4-aminopyridine.
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I cannot communicate effectively due to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Healing rate
Secondary study objectives
Scar formation
Scar sensitivity
Skin-graft rate

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group A: 4-aminopyridineActive Control1 Intervention
Dalfampridine (generic) 10 mg capsule PO every 12 hours
Group II: Group B: PlaceboPlacebo Group1 Intervention
Placebo - 1 capsule PO every 12 hours

Find a Location

Who is running the clinical trial?

John ElfarLead Sponsor
3 Previous Clinical Trials
298 Total Patients Enrolled
John Elfar, MDPrincipal InvestigatorUniversity of Arizona
4 Previous Clinical Trials
366 Total Patients Enrolled
~133 spots leftby Jun 2028
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