4-Aminopyridine for Burns

Recruiting in Palo Alto (17 mi)

Overseen ByJohn Elfar, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: John Elfar

Prior Safety Data

Trial Summary

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.

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 have burns covering at least 6cm2 of my skin.

I have second-degree burns at most.

I have burns that occurred within the last week.

I am between 18 and 80 years old.

Exclusion Criteria

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

I am unable to understand and give consent for treatment.

I am willing to follow all study requirements.

I have a history of neurological disorders like multiple sclerosis or stroke.

I am currently taking medication that includes OCT2 inhibitors.

I am currently taking aminopyridine medications.

I am allergic to AMPYRA® or 4-aminopyridine.

I cannot communicate effectively due to my condition.

Participant Groups

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.

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