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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625455
First Posted: June 21, 2012
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
  Purpose
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 Pruritus Drug: Aprepitant Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625455


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

Publications:

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
First Submitted: June 19, 2012
First Posted: June 21, 2012
Results First Submitted: November 30, 2016
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017
Last Verified: March 2017

Keywords provided by Nancy J. Brown, Vanderbilt University:
Sezary Syndrome
Pruritus
Aprepitant
Neurokinin-1

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