Pregabalin for Pruritus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pruritus+3 More
Pregabalin - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Pruritus
  • Epidermolysis Bullosa
  • Neuropathic Pain

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Pruritus

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 24 weeks

12 weeks
Difference in the mean pain scores between pregabalin and placebo group: VAS
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
12 weerks
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
24 weeks
Changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient portion score in the intervention versus placebo
Interventional procedure
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.
Pain
Difference in the average itch score as assessed using VAS between the first and the second treatment periods (period effect).
Difference in the average pain score assessed using VAS between first and second treatment periods (period effect)
Proportion of patients experiencing adverse events, minor, severe and serious (life-threatening)
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients that dropped out of the study as a result of an adverse event

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Pruritus

Trial Design

2 Treatment Groups

Pregabalin followed by placebo
1 of 2
Placebo followed by Pregabalin
1 of 2
Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: Pregabalin · No Placebo Group · Phase 3

Pregabalin followed by placebo
Drug
Experimental Group · 1 Intervention: Pregabalin · Intervention Types: Drug
Placebo followed by Pregabalin
Drug
Experimental Group · 1 Intervention: Pregabalin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
638 Previous Clinical Trials
6,816,077 Total Patients Enrolled
1 Trials studying Pruritus
Epidemolysis Bullosa Research PartnershipUNKNOWN

Eligibility Criteria

Age < 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a VAS score of 4 or more on a 0-10 VAS scale at night over 2 weeks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.