Clinical Trial: A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Study of Neurokinin-1 Receptor Antagonist Serlopitant in Subjects With Prurigo Nodularis

Brief Summary: The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor antagonist is safe and effective for treatment of prurigo nodularis versus placebo.

Detailed Summary: The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 14 weeks
Sponsor: Menlo Therapeutics Inc.

Current Primary Outcome: The primary endpoints are pairwise comparisons between treatments of Visual Analog Score (VAS) score over 24 hour period of serlopitant 5 mg tablets and placebo taken once daily for 8 weeks for prurigo nodularis [ Time Frame: 8 weeks ]

Original Primary Outcome: The primary endpoints are pairwise comparisons between treatments of Visual Analog Score (VAS) score over 24 hour period of VPD-737 5-mg tablets and placebo taken once daily for 8 weeks for prurigo nodularis [ Time Frame: 8 weeks ]

Current Secondary Outcome: Mean change from Baseline in Visual Rating Scale (VRS). [ Time Frame: 8 weeks ]

Original Secondary Outcome: Same as current

Information By: Menlo Therapeutics Inc.

Dates:
Date Received: July 14, 2014
Date Started: July 2014
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016