Ignite Creation Date:
2024-05-06 @ 8:01 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02654483
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2016-01-11
Brief Title:
Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
Sponsor:
Jean Yuh Tang
Organization:
Stanford University
Study Overview
Official Title:
A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our goal is to determine whether daily oral administration of VPD-737 5 mg is effective and safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa EB
Detailed Description:
Itch is the most common complaint reported by patients with EB of all subtypes and there is no current effective treatment Itch often triggers scratching that creates new wounds and increases EB disease severity
This study aims to target the physiological mechanisms of pruritus itch in patients with EB Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 NK1 which is expressed in the central nervous system and the skin
VPD-737 serlopitant a novel drug that inhibits the NK1 receptor has been shown to reduce severe itch in a previous study of 257 adult patients with chronic pruritus
Each patient will be un-blinded individually after completing 3 months of study period
All patients who complete the study will be offered a 2-month period on active drug Patient who received active drug in the first period will be contacted and asked if they would like to continue on active drug for an additional 2 months
Patients who received placebo in the first period will be contacted and asked if they would like to repeat the study on open label for 2 months
This study aims to target the physiological mechanisms of pruritus itch in patients with EB Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 NK1 which is expressed in the central nervous system and the skin
VPD-737 serlopitant a novel drug that inhibits the NK1 receptor has been shown to reduce severe itch in a previous study of 257 adult patients with chronic pruritus
Each patient will be un-blinded individually after completing 3 months of study period
All patients who complete the study will be offered a 2-month period on active drug Patient who received active drug in the first period will be contacted and asked if they would like to continue on active drug for an additional 2 months
Patients who received placebo in the first period will be contacted and asked if they would like to repeat the study on open label for 2 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None