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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sezary Syndrome, Pruritus

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aprepitant<br>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. | Drug: Aprepitant<br>* 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.<br>* Other names: Emend;|
| Placebo Comparator: Placebo<br>Matching placebo will be given in place of aprepitant | Drug: Placebo<br>* Placebo will be given orally for a total of 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sezary Syndrome, Pruritus, Aprepitant, Neurokinin-1