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

Phase 4

Terminated

• Conditions: Pruritus; Sezary Syndrome
• Interventions: Drug: Aprepitant; Drug: Placebo

• Registration Number: NCT01625455
• Lead Sponsor: Vanderbilt University Medical Center

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 Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Results First Submitted: 2016-11-30
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Results First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Known Sezary Syndrome
• Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale > 4.
• Age 18 through 80 years of age.
• Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to study participation.

Exclusion Criteria

• Known hepatic impairment (defined as liver function tests >3 times the upper limit of normal).
• Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).
• Concurrent use of pimozide, terfenadine, astemizole, or cisapride.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aprepitant	Aprepitant	Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
Placebo	Placebo	Matching placebo will be given in place of aprepitant

Primary Outcome Measures

Name	Time	Method
Severity of Pruritus	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States