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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01625455
First received: June 19, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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
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).


Estimated Enrollment: 16
Study Start Date: February 2012
Estimated Primary Completion Date: February 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: Sugar Pill Drug: Placebo
Placebo will be given orally for a total of 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Brittany Straka, MD (615) 343-6479 brittany.t.straka@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37235
Contact: Brittany Straka, MD    615-343-6479    brittany.t.straka@vanderbilt.edu   
Principal Investigator: Nancy Brown, MD         
Sub-Investigator: John Zic, MD         
Sub-Investigator: Laura McGirt, MD         
Sub-Investigator: Brittany Straka, MD         
Sponsors and Collaborators
Vanderbilt University
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
Study First Received: June 19, 2012
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Sezary Syndrome
Pruritus
Aprepitant
Neurokinin-1

Additional relevant MeSH terms:
Pruritus
Sezary Syndrome
Skin Diseases
Skin Manifestations
Signs and Symptoms
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
Neurokinin A
Substance P
Aprepitant
Fosaprepitant
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists

ClinicalTrials.gov processed this record on September 14, 2014