Clinical Trial: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Brief Summary: The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.

Detailed Summary:
Sponsor: Vanderbilt University Medical Center

Current Primary Outcome: Severity of Pruritus [ Time Frame: one week ]

The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.


Original Primary Outcome: Severity of Pruritus [ Time Frame: one week ]

The primary endpoint is the severity of pruritus as measured on the visual analogue scale.


Current Secondary Outcome: Quality of Life [ Time Frame: one week ]

The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).

For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life.

Maximum response for all ten questions 30, minimum 0.



Original Secondary Outcome: Quality of Life [ Time Frame: one week ]

The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).


Information By: Vanderbilt University Medical Center

Dates:
Date Received: June 19, 2012
Date Started: February 2012
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017