Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03836001
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2019-02-07
Brief Title:
A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa
Status:
COMPLETED
Status Verified Date:
2023-01
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:
To determine if Serlopitant when taken by mouth is safe and works on itch in patients aged 13 and above with EB
Detailed Description:
The investigator will determine whether more patients taking serlopitant 5 mg daily as compared to placebo can achieve at least a 3-point reduction in the 24-hour Average Itch Numeric Rating Scale NRS following two months of treatment
Secondary objectives include
1 comparative weekly change in daily worst itch NRS
2 comparative weekly change in daily average itch NRS
3 the proportion of patients who achieve at least 30 or 50 reduction in Average Itch NRS at month 2
4 proportion of patients achieving 2-point and 4-point reductions in Average Itch NRS at month 2
5 Patient Global Impression of Change PGIC at month 2 the change in participant static assessment of itch at month 2 and
6 assessment of the safety of serlopitant in adolescents 13 yo and adults with epidermolysis bullosa-related itch
Secondary objectives include
1 comparative weekly change in daily worst itch NRS
2 comparative weekly change in daily average itch NRS
3 the proportion of patients who achieve at least 30 or 50 reduction in Average Itch NRS at month 2
4 proportion of patients achieving 2-point and 4-point reductions in Average Itch NRS at month 2
5 Patient Global Impression of Change PGIC at month 2 the change in participant static assessment of itch at month 2 and
6 assessment of the safety of serlopitant in adolescents 13 yo and adults with epidermolysis bullosa-related itch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None