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

Phase 4TerminatedNCT01625455

Vanderbilt University Medical Center7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sezary Syndrome Pruritus

Interventions

AprepitantDRUG

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.

PlaceboDRUG

Placebo will be given orally for a total of 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Severity of Pruritus

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.

Time frame: one week

Secondary Outcomes

Quality of Life

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.

Time frame: one week

Data from ClinicalTrials.gov

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