Recruiting
Phase 2

4-AP

Sponsor:

John Elfar

Code:

NCT06596434

Conditions

Burns

Second Degree Burn

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Drug: 4-Aminopyridine

Placebo

Study Details

Brief summary:

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.

Conditions

Burns

Second Degree Burn

Wounds and Injuries

Study ID

NCT06596434

Start date

Jan 1, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A: 4-aminopyridine

Dalfampridine (generic) 10 mg capsule PO every 12 hours

placebo comparator: Group B: Placebo

Placebo - 1 capsule PO every 12 hours

Interventions

Drug: 4-Aminopyridine

Active study drug

Placebo

Placebo comparator

Primary outcome measure

  • Healing rate [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Carly J Deal, MPH

520-626-1588carlyjdeal@arizona.edu

Veronica Rangel, BS

5206264024vrangel@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Carly J Deal

520-626-1588carlyjdeal@arizona.edu

Veronica Rangel, BS

5206164024vrangel@arizona.edu

More Information

Sponsor

John Elfar

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • 4-aminopyridine
  • 4-AP
  • Burns
  • Second degree burn
  • Wounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Elfar on 2026-03-05.