Back to results

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

Primary Purpose

Sezary Syndrome, Pruritus

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aprepitant

Placebo

About this trial

This is an interventional treatment trial for Sezary Syndrome focused on measuring Sezary Syndrome, Pruritus, Aprepitant, Neurokinin-1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aprepitant

Placebo

Arm Description

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.

Matching placebo will be given in place of aprepitant

Outcomes

Primary Outcome Measures

Severity of Pruritus

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

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.

Full Information

NCT ID

NCT01625455

First Posted

June 19, 2012

Last Updated

March 30, 2017

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01625455

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Difficulty recruiting.

Study Start Date

February 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sezary Syndrome, Pruritus

Keywords

Sezary Syndrome, Pruritus, Aprepitant, Neurokinin-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aprepitant

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo will be given in place of aprepitant

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

Emend

Intervention Description

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 Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be given orally for a total of 7 days.

Primary Outcome Measure Information:

Title

Severity of Pruritus

Description

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.

Time Frame

one week

Secondary Outcome Measure Information:

Title

Quality of Life

Description

Time Frame

one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy J Brown, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37235

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11167693

Citation

Bernengo MG, Novelli M, Quaglino P, Lisa F, De Matteis A, Savoia P, Cappello N, Fierro MT. The relevance of the CD4+ CD26- subset in the identification of circulating Sezary cells. Br J Dermatol. 2001 Jan;144(1):125-35. doi: 10.1046/j.1365-2133.2001.04014.x.

Results Reference

background

PubMed Identifier

21039410

Citation

Booken N, Heck M, Nicolay JP, Klemke CD, Goerdt S, Utikal J. Oral aprepitant in the therapy of refractory pruritus in erythrodermic cutaneous T-cell lymphoma. Br J Dermatol. 2011 Mar;164(3):665-7. doi: 10.1111/j.1365-2133.2010.10108.x. Epub 2011 Jan 28. No abstract available.

Results Reference

background

PubMed Identifier

19797294

Citation

Duval A, Dubertret L. Aprepitant as an antipruritic agent? N Engl J Med. 2009 Oct 1;361(14):1415-6. doi: 10.1056/NEJMc0906670. No abstract available.

Results Reference

background

PubMed Identifier

20950328

Citation

Cevikbas F, Steinhoff M, Ikoma A. Role of spinal neurotransmitter receptors in itch: new insights into therapies and drug development. CNS Neurosci Ther. 2011 Dec;17(6):742-9. doi: 10.1111/j.1755-5949.2010.00201.x. Epub 2010 Oct 15.

Results Reference

background

PubMed Identifier

12892317

Citation

Lambeir AM, Durinx C, Scharpe S, De Meester I. Dipeptidyl-peptidase IV from bench to bedside: an update on structural properties, functions, and clinical aspects of the enzyme DPP IV. Crit Rev Clin Lab Sci. 2003 Jun;40(3):209-94. doi: 10.1080/713609354.

Results Reference

background

PubMed Identifier

1372050

Citation

Ahmad S, Wang L, Ward PE. Dipeptidyl(amino)peptidase IV and aminopeptidase M metabolize circulating substance P in vivo. J Pharmacol Exp Ther. 1992 Mar;260(3):1257-61.

Results Reference

background

PubMed Identifier

680144

Citation

Heymann E, Mentlein R. Liver dipeptidyl aminopeptidase IV hydrolyzes substance P. FEBS Lett. 1978 Jul 15;91(2):360-4. doi: 10.1016/0014-5793(78)81210-1. No abstract available.

Results Reference

background

PubMed Identifier

8388031

Citation

Mussap CJ, Geraghty DP, Burcher E. Tachykinin receptors: a radioligand binding perspective. J Neurochem. 1993 Jun;60(6):1987-2009. doi: 10.1111/j.1471-4159.1993.tb03484.x.

Results Reference

background

PubMed Identifier

18525044

Citation

Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008 Jun 5;358(23):2482-94. doi: 10.1056/NEJMra0706547. No abstract available.

Results Reference

background

PubMed Identifier

17540844

Citation

Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31. Erratum In: Blood. 2008 May 1;111(9):4830.

Results Reference

background

PubMed Identifier

11756953

Citation

Vonderheid EC, Bernengo MG, Burg G, Duvic M, Heald P, Laroche L, Olsen E, Pittelkow M, Russell-Jones R, Takigawa M, Willemze R; ISCL. Update on erythrodermic cutaneous T-cell lymphoma: report of the International Society for Cutaneous Lymphomas. J Am Acad Dermatol. 2002 Jan;46(1):95-106. doi: 10.1067/mjd.2002.118538.

Results Reference

background

PubMed Identifier

32632956

Citation

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Results Reference

derived

PubMed Identifier

30140912

Citation

Zic JA, Straka BT, McGirt LY, Nian H, Yu C, Brown NJ. Aprepitant for the Treatment of Pruritus in Sezary Syndrome: A Randomized Crossover Clinical Trial. JAMA Dermatol. 2018 Oct 1;154(10):1221-1222. doi: 10.1001/jamadermatol.2018.2510.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs