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

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Aprepitant; Fosaprepitant; Neurokinin A; Substance P

Criteria

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.