Trial Information
Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Severity of pruritus
Outcome Description:
The primary endpoint is the severity of pruritus as measured on the visual analogue scale.
Outcome Time Frame:
one week
Safety Issue:
No
Principal Investigator
Nancy J Brown, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt University
Authority:
United States: Institutional Review Board
Study ID:
110806
NCT ID:
NCT01625455
Start Date:
February 2012
Completion Date:
Related Keywords:
- Sezary Syndrome
- Pruritus
- Sezary Syndrome
- Pruritus
- Aprepitant
- Neurokinin-1
- Pruritus
- Sezary Syndrome
Name | Location |
Vanderbilt University Medical Center |
Nashville, Tennessee 37232-2516 |