Recruiting
Phase 2

4-Aminopyridine

Sponsor:

John Elfar

Code:

NCT06333171

Conditions

Wounds

Wound of Skin

Wound Heal

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

4-Aminopyridine

Placebo

Study Details

Brief summary:

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.

The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.

The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.

Conditions

Wounds

Wound of Skin

Wound Heal

Wounds and Injuries

Study ID

NCT06333171

Start date

Sep, 2025

Status verified date

Sep, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Otherwise healthy adult patients without skin conditions effecting the skin of the axilla or upper inner arm.
  • Cognitive ability to evaluate wound healing, report sensory and motor deficit during examination.
  • Eligible for standard of care plan for wound closure by secondary intention (normal healing without intervention).
  • Adults subject aged 18-70
  • 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

150 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

4-Aminopyridine

Active study drug

Placebo

Placebo comparator

Primary outcome measure

  • Return of skin integrity and wound closure after skin punch biopsy [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Andrea Horne

520-626-6456ahh@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Andrea Horne

520-626-6456ahh@arizona.edu

More Information

Sponsor

John Elfar

Last update posted

Sep 3, 2025

Last verified

Sep, 2025

Keywords

  • 4 aminopyridine
  • wound healing

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 2025-09-03.