Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Severity of Pruritus
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Known Sezary Syndrome
- •Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale >
- •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.
Arms & Interventions
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.
Intervention: Aprepitant (Drug)
Placebo
Matching placebo will be given in place of aprepitant
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Quality of Life(one week)
Investigators
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