Pregabalin Treatment for RDEB Pain and Itch
Pain, Neuropathic, Itch, Epidermolysis Bullosa
About this trial
This is an interventional treatment trial for Pain, Neuropathic
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pregabalin followed by placebo
Placebo followed by Pregabalin
The study has a crossover design. Participants in this arm will receive pregabalin during the first study treatment period for ten weeks and placebo during their second ten-week treatment period . The dose will depend on the participant's weight and phase of treatment period. Each treatment period consists of 4 weeks of escalating dose until the desired maximum , 4 weeks of active treatment and 2 weeks of titrating down.
Participants will receive placebo during the first treatment period of the study(10 weeks) followed by 10 weeks of pregabalin treatment . The dose will depend on the participant's weight and phase of the treatment period . Each treatment period consists of 3 phases: 4 weeks of escalating dose until the desired maximum, 4 weeks of active treatment and 2 weeks of titrating down.