Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin



Status:Recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 120
Updated:2/21/2019
Start Date:January 22, 2019
End Date:April 2020
Contact:Menlo Study Director
Email:capstone@menlotx.com
Phone:650-486-1416

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and
Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin


Inclusion:

- Male or female, age 18 years or older at consent.

- The subject must have ongoing chronic pruritus

- The subject's pruritus is assessed by the investigator to be of unknown origin at
baseline.

- Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the
Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to
Baseline visit indicating an appropriate pruritus level for the study.

- The pruritus must have been unresponsive to prior treatment with emollients.

- The subject's pruritus must be present on multiple segments of the body

- Willing and able to complete daily eDiary entries within a consistent timeframe for
the duration of the study

- All females who are of childbearing potential must be willing to practice highly
effective contraception and not be pregnant or nursing

- Willing to comply with study visits and study related requirements including providing
written informed consent.

- Adequate cognitive and physical ability, in the investigator's opinion, to comply with
study visits and study related requirements including providing written informed
consent

Exclusion

- Prior treatment with any NK1-receptor antagonists

- Known dermatologic or systemic condition(s), other than dry skin, that is considered
by the investigator to be the primary cause of current pruritus.

- Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules,
or history of thyroid malignancy.

- Use of an excluded therapy within 3 weeks prior to randomization

- Treatment with any investigational therapy within 3 weeks prior to randomization.

- Serum creatinine, total bilirubin, alanine aminotransferase or aspartate
aminotransferase > 2.5 times the upper limit of normal during screening.

- History of malignancy within 3 years prior to randomization, with the (actinic
keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of
skin).

- Any known major psychiatric diagnosis that would impact the subject's ability to
complete the study

- Suicidal ideation within 3 years prior to randomization, or any history of suicide
attempt.

- Known use of recreational drugs.

- Documented history of parasitic infection, including skin parasites such as scabies,
within 12 weeks prior to randomization.

- Presence of clinically significant dementia, intellectual impairment, or any medical
condition or disability that, in the investigator's opinion, could interfere with the
assessment of safety or efficacy in this trial or compromise the safety of the
subject.

- History of hypersensitivity to serlopitant or any of its components.

- Planned or anticipated major surgical procedure or other activity that would interfere
with the subject's ability to comply with protocol-mandated assessments (e.g. extended
international travel) during the subject's participation in the study.
We found this trial at
27
sites
16003 Florida Avenue
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Brighton, Massachusetts 02135
?
mi
from
Brighton, MA
Click here to add this to my saved trials
Bronx, New York 10458
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Denver, Colorado
?
mi
from
Denver, CO
Click here to add this to my saved trials
Dublin, Ohio 43016
?
mi
from
Dublin, OH
Click here to add this to my saved trials
Fremont, California 94538
?
mi
from
Fremont, CA
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
Hot Springs, Arkansas 72022
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Johnston, Rhode Island
?
mi
from
Johnston, RI
Click here to add this to my saved trials
Las Vegas, Nevada
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37215
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
330 Changebridge Road
Ocean Township, New Jersey 07712
?
mi
from
Ocean Township, NJ
Click here to add this to my saved trials
Pflugerville, Texas
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Joseph, Missouri
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Savannah, Georgia
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Walla Walla, Washington 09362
?
mi
from
Walla Walla, WA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
West Palm Beach, Florida 33406
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials