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


Phase 4
18 Years
80 Years
Open (Enrolling)
Both
Sezary Syndrome, Pruritus

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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 CenterNashville, Tennessee  37232-2516