Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT06596434
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06596434
Study Brief:
Protocol Section:
NCT06596434