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

This study has been terminated.
(Difficulty recruiting.)
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: June 19, 2012
Last updated: March 18, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Sezary Syndrome
Drug: Aprepitant
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Severity of pruritus [ Time Frame: one week ] [ Designated as safety issue: No ]
    The primary endpoint is the severity of pruritus as measured on the visual analogue scale.

Secondary Outcome Measures:
  • Quality of life [ Time Frame: one week ] [ Designated as safety issue: No ]
    The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).

Enrollment: 7
Study Start Date: February 2012
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aprepitant
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
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.
Other Name: Emend
Placebo Comparator: Placebo
Matching placebo will be given in place of aprepitant
Drug: Placebo
Placebo will be given orally for a total of 7 days.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01625455

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Nancy J Brown, MD Vanderbilt University
  More Information


Responsible Party: Nancy J. Brown, Chair and Physician-in-chief, Department of Medicine, Hugh Jackson Morgan Professor Medicine and Pharmacology, Vanderbilt University School of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01625455     History of Changes
Other Study ID Numbers: 110806 
Study First Received: June 19, 2012
Last Updated: March 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Sezary Syndrome

Additional relevant MeSH terms:
Sezary Syndrome
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Pathologic Processes
Signs and Symptoms
Skin Diseases
Skin Manifestations
Neurokinin A
Substance P
Autonomic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016