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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03928093
Eligibility Criteria:
Inclusion Criteria:
* Age: \> 8 - 40 years (we selected this range due to lack of data in younger population and the difficulty in getting patient reported outcomes in younger patients)
* Diagnosis of RDEB (by a dermatologist and/or EB specialist and/or genetic confirmation)
* Evidence of neuropathy defined by: thermal sensory loss (determined by a thermal roller, ROLLTEMP2, Sometic, Sweden) 14 and \> 4/10 score using a screening tool for neuropathic pain, the DN4 questionnaire 15
* Pain intensity of \> 4/10 on a 0-10 VAS scale measured daily (reduced frequency is also acceptable) at night over 2 weeks
* Itch intensity of \> 4/10 on a 0-10 VAS scale measures daily (reduced frequency is also acceptable) at night over 2 weeks
* Consent to follow with study procedures
Exclusion Criteria:
* Intolerance and/or allergy to Pregabalin or gabapentin
* Lactose intolerance (placebo capsules contain lactose)
* Pregabalin use within 2 weeks before study enrolment
* Ongoing treatment with gabapentin, amitriptyline, duloxetine, nortriptyline, other tricyclics or SNRIs
* Medical conditions that would be considered as contraindications for pregabalin treatment (ischemic heart disease, cardiac dysrhythmia, glaucoma, history of urinary retention)
* Pregnancy
* History of use of restrictive substances or alcohol abuse
* Allergy to gelatin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
40 Years
Study:
NCT03928093
Study Brief:
Protocol Section:
NCT03928093