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

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Sezary Syndrome; Pruritus

Treatments: Drug: Placebo; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT01625455

110806

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups, including a placebo group

Aprepitant

Active Comparator group

Description:

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.

Treatment:

Drug: Aprepitant

Placebo

Placebo Comparator group

Description:

Matching placebo will be given in place of aprepitant

Treatment:

Drug: Placebo