Clinical trial NCT01625455: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
Official title: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sezary Syndrome
Pruritus
Keywords: Sezary Syndrome
Pruritus
Aprepitant
Neurokinin-1
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Severity of Pruritus
timeFrame: one week
Secondary outcomes:
measure: Quality of Life
timeFrame: one week
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Nancy J Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Vonderheid EC, Bernengo MG, Burg G, Duvic M, Heald P, Laroche L, Olsen E, Pittelkow M, Russell-Jones R, Takigawa M, Willemze R; ISCL. Update on erythrodermic cutaneous T-cell lymphoma: report of the International Society for Cutaneous Lymphomas. J Am Acad Dermatol. 2002 Jan;46(1):95-106. doi: 10.1067/mjd.2002.118538.
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citation: Zic JA, Straka BT, McGirt LY, Nian H, Yu C, Brown NJ. Aprepitant for the Treatment of Pruritus in Sezary Syndrome: A Randomized Crossover Clinical Trial. JAMA Dermatol. 2018 Oct 1;154(10):1221-1222. doi: 10.1001/jamadermatol.2018.2510.