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

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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
Miami, Florida 33136
2322
mi
from 91732
Miami, FL
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Aventura, Florida 33180
2320
mi
from 91732
Aventura, FL
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Brighton, Massachusetts 02135
?
mi
from 91732
Brighton, MA
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Bronx, New York 10458
?
mi
from 91732
Bronx, NY
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Denver, Colorado
818
mi
from 91732
Denver, CO
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Dublin, Ohio 43016
1954
mi
from 91732
Dublin, OH
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Fremont, California 94538
327
mi
from 91732
Fremont, CA
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High Point, North Carolina 27262
1997
mi
from 91732
High Point, NC
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Hot Springs, Arkansas 72022
?
mi
from 91732
Hot Springs, AR
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Indianapolis, Indiana 46290
1792
mi
from 91732
Indianapolis, IN
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16003 Florida Avenue
Jacksonville, Florida 32209
2112
mi
from 91732
Jacksonville, FL
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Johnston, Rhode Island
?
mi
from 91732
Johnston, RI
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Las Vegas, Nevada
217
mi
from 91732
Las Vegas, NV
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Los Angeles, California
13
mi
from 91732
Los Angeles, CA
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Morristown, New Jersey 07960
?
mi
from 91732
Morristown, NJ
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Nashville, Tennessee 37215
?
mi
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Nashville, TN
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Norfolk, Virginia
2337
mi
from 91732
Norfolk, VA
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330 Changebridge Road
Ocean Township, New Jersey 07712
2414
mi
from 91732
Ocean Township, NJ
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Pflugerville, Texas
1215
mi
from 91732
Pflugerville, TX
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Raleigh, North Carolina 27612
2218
mi
from 91732
Raleigh, NC
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Saint Joseph, Missouri
1334
mi
from 91732
Saint Joseph, MO
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San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
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Savannah, Georgia
2129
mi
from 91732
Savannah, GA
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Spokane, Washington 99202
?
mi
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Spokane, WA
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Walla Walla, Washington 09362
?
mi
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Walla Walla, WA
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Warwick, Rhode Island 02886
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Warwick, RI
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West Palm Beach, Florida 33406
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from 91732
West Palm Beach, FL
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