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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 Identifier:
First received: June 19, 2012
Last updated: March 30, 2017
Last verified: March 2017
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
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, 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 Nancy J. Brown, Vanderbilt University:

Primary Outcome Measures:
  • Severity of Pruritus [ Time Frame: one week ]
    The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: one week ]

    The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).

    For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life.

    Maximum response for all ten questions 30, minimum 0.

Enrollment: 7
Study Start Date: February 2012
Study Completion Date: July 2016
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   (Adult, Senior)
Sexes Eligible for Study:   All
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 identifier: NCT01625455

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Vanderbilt University Medical Center
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 Identifier: NCT01625455     History of Changes
Other Study ID Numbers: 110806
Study First Received: June 19, 2012
Results First Received: November 30, 2016
Last Updated: March 30, 2017

Keywords provided by Nancy J. Brown, Vanderbilt University:
Sezary Syndrome

Additional relevant MeSH terms:
Sezary Syndrome
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Neurokinin A
Substance P
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists processed this record on May 25, 2017