4-Aminopyridine to Treat Skin Burns
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Burns, Second Degree Burn, Wounds and Injuries
In brief
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.
Key facts
- Study ID
- NCT06596434
- Run by
- John Elfar
- People needed
- 200
- Starts
- 2026-01-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Adults aged 18-80
- Ability to give written informed consent.
- Capable of safely coming in for follow up visits on all scheduled appointments.
You may not qualify if…
- 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.
- History of difficult compliance with timely follow up
- Patients outside the age range
- Unable to provide informed consent.
- Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
- Patients with a concomitant traumatic brain injury.
- Patients unable to communicate.
- Patients unwilling to complete the study requirements.
- Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.
- Pregnancy, breastfeeding or incarcerated individuals.
- Non-English speaking
- Patients unable or unwilling to take calibrated (with gauge) photographs of their wounds
Where it is running
- University of Arizona — Tucson, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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