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New treatment option for Burns
Official title 4-Aminopyridine to Treat Skin Burns
ClinicalTrials.gov ID: NCT06596434
What this study is testing
What is Drug: 4-Aminopyridine?
Drug: 4-Aminopyridine is an investigational medicine, being studied as a potential treatment for burns.
Also referred to as 4AP, 4-AP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.