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Gamma-Aminobutyric Acid (GABA) Analog

Pregabalin for Epidermolysis Bullosa

Phase 3
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: > 8 - 40 years
Diagnosis of RDEB (by a dermatologist and/or EB specialist and/or genetic confirmation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is to study whether pregabalin is a safe and effective treatment for people with a rare skin condition called recessive dystrophic epidermolysis bullosa who also have neuropathic pain and itch.

Who is the study for?
This trial is for individuals aged 8-40 with RDEB, experiencing neuropathic pain and itch. Participants must have a confirmed diagnosis of RDEB, evidence of neuropathy, and significant daily pain and itch levels. Exclusions include recent Pregabalin or gabapentin use, ongoing treatment with certain antidepressants or SNRIs, specific medical conditions like heart disease or glaucoma, lactose intolerance, allergy to gelatin or the study drug itself.Check my eligibility
What is being tested?
The trial tests Pregabalin's effectiveness in managing neuropathic pain and itch in RDEB patients compared to a placebo. Each participant will receive both the medication and placebo at different times (cross-over design), serving as their own control to provide data on dosage, efficacy, safety measures for future larger trials.See study design
What are the potential side effects?
Pregabalin may cause dizziness, sleepiness; some people might experience swelling hands/feet or weight gain. Rarely it can lead to an allergic reaction which could be serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 40 years old.
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I have been diagnosed with RDEB by a specialist or through genetic testing.
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I experience significant numbness or pain due to nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in the mean pain scores between pregabalin and placebo group: VAS
Secondary outcome measures
Changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient portion score in the intervention versus placebo
Interventional procedure
Difference in the average itch score as assessed using VAS between the first and the second treatment periods (period effect).
+5 more
Other outcome measures
Correlation between itch score (as measured by VAS),iscorEB patient portion and QOLEB (for patients over 18 yrs) total scores.
Correlation between itch score( as measured by VAS) and iscorEB clinician and Epidermolysis Bullosa Disease Activity and Scarring Index(EBDASI)
Correlation between pain score (as measured by VAS), iscorEB patient portion score and QOLEB (for patients over 18 yrs) total scores.
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pregabalin followed by placeboExperimental Treatment1 Intervention
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.
Group II: Placebo followed by PregabalinExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
687 Previous Clinical Trials
6,945,032 Total Patients Enrolled
1 Trials studying Neuropathic Pain
120 Patients Enrolled for Neuropathic Pain
Epidemolysis Bullosa Research PartnershipUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions has Pregabalin been shown to improve?

"Pregabalin is most often used as a fibromyalgia treatment, but it has also been found to be helpful for patients with anxiety disorders, vitamin b12 deficiency, and spinal cord damage."

Answered by AI

Are there currently any available openings for this research project?

"The clinical trial in question is not actively enrolling patients according to the most recent update on October 26th, 2022. The study was first posted on August 7th, 2019. There are currently 243 other trials that are actively looking for participants."

Answered by AI

What is the maximum participant capacity for this experiment?

"This particular study is not looking for new participants at this moment. The clinical trial was initially posted on 8/7/2019 and updated last on 10/26/2022. If you're interested in other trials, there are 222 studies currently underway that focus on pruritus and 21 additional trials investigating Pregabalin."

Answered by AI

Does this research include testing on individuals older than 55 years of age?

"The age requirement for this clinical trial is between 8 and 40 years old."

Answered by AI

Pregabalin has received regulatory approval from which governmental organization?

"Pregabalin has received a safety score of 3. This is due to Phase 3 trial data, which demonstrates both efficacy and multiple rounds of safe use."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pregabalin Treatment for RDEB Pain and Itch
Elena Pope 2019. "Pregabalin Treatment for RDEB Pain and Itch". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03928093.
~0 spots leftby Apr 2025
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