4-Aminopyridine to Treat Skin Burns

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Elfar

About 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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Drug: 4-Aminopyridine
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

John Elfar

Lead sponsor

University of Arizona

Sponsor institution