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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Sezary Syndrome, Pruritus

In brief

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.

Key facts

Study ID

NCT01625455

Run by

Vanderbilt University Medical Center

People needed

7

Starts

2012-02-01

Expected to finish

2016-07-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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