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Notalgia paresthetica (NP) is a common, underdiagnosed condition that feels like an intense itching, burning, prickly (pins-and-needles) sensation between the shoulder blades or upper spine. Signs and symptoms of notalgia paraesthetica in the affected area may also include:

• Darker or lighter patches of skin (usually between the size of a golf ball and a grapefruit)
• Scratch marks or scarring
• Thick or leathery skin

We are currently recruiting subjects aged 18 years and older with moderate to severe itch due to Notalgia Paresthetica (NP) to participate in an investigational trial. The primary purpose of this research is to evaluate the safety and effectiveness of an oral (taken by mouth) investigational drug called Difelikefalin in participants with NP. 

The study consists of taking an oral study treatment twice daily. You will have a 3 out of 4 (75%) chance of receiving the investigational treatment rather than placebo (pill that does not contain any treatment) for the 8 weeks of treatment. After the 8 weeks, there is a 2-week discontinuation period where you will have stopped taking the treatment. You will have a total of 7 in-person visits.

Participation will last approximately 15 weeks, including up to 4-weeks for screening and a 2-week post-treatment follow-up visit. Visits take approximately 30 minutes to 2.5 hours each, except for the screening visit which may take up to 3 hours. 

Blood samples will be collected from all participants at Screening, Day 1,  week 2,  week 4, week 8, and the safety follow-up visit. 

An electrocardiogram to check heart health will be taken at visit 1 and again at visit 6. 

Compensation for time and travel may be available. There will be no cost to you for taking part in this study. You will be provided with all study medication, examinations and medical care related to the study at no cost to you.

See if you are eligible for the trial!


Visits
Drug administered on which days
Total
Length
Procedures
Study Length
Days
Day 1, 15, 29, and 57
Total
6 + 1 follow-up
Length
up to 3 hours
Procedures
Blood samples, electrocardiogram
Study Length
approx. 15 weeks
Summary
We are currently recruiting subjects aged 18 years and older with itch due to Notalgia Paresthetica (NP) to participate in an investigational trial. The main purpose of this trial is to evaluate how safe and effective the investigative drug Difelikefalin is when taken by mouth in patients with NP.
Condition
Notalgia paresthetica
Treatment
Difelikefalin

There are 31 locations for this study

Innovaderm Research Inc.

Innovaderm Research Inc.

Montréal, Quebec, H2X 2V1, Canada
Austin Institute for Clinical Research

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States
Clinical Trials Management

Clinical Trials Management

Metairie, Louisiana, 70006, United States
Advanced Clinical Research Institute

Advanced Clinical Research Institute

Tampa, Florida, 33602, United States
Driven Research, LLC

Driven Research, LLC

Coral Gables, Florida, 33134, United States
Dermatology Research Associates: Howard Sofen, MD

Dermatology Research Associates: Howard Sofen, MD

Los Angeles, California, 90045, United States
Austin Institute for Clinical Research (Houston Location)

Austin Institute for Clinical Research (Houston Location)

Houston, Texas, 77056, United States
Progressive Clinical Research

Progressive Clinical Research

San Antonio, Texas, 78213, United States
ALLCUTIS Research, LLC

ALLCUTIS Research, LLC

Portsmouth, New Hampshire, 03810, United States
The Indiana Clinical Trials Center

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States
DelRicht Research

DelRicht Research

New Orleans, Louisiana, 70115, United States
DelRicht Research

DelRicht Research

Baton Rouge, Louisiana, 70809, United States
DelRicht Research

DelRicht Research

Thoompson's Station, Tennessee, 37179, United States
Skin Care Research

Skin Care Research

Boca Raton, Florida, 33486, United States
Glick Skin Institute

Glick Skin Institute

Margate, Florida, 33073, United States
Dermatology Treatment and Research Center

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States
First OC Dermatology Research Inc.

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States
Dermatology Specialists of Spokane

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States
Clinical Trials Institute of Northwest Arkansas

Clinical Trials Institute of Northwest Arkansas

Fayetteville, Arkansas, 72703, United States
Options Research Group

Options Research Group

West Lafayette, Indiana, 47906, United States
Optima Research

Optima Research

Boardman, Ohio, 44512, United States
Oshawa Clinic Dermatology Trials

Oshawa Clinic Dermatology Trials

Oshawa, Ontario, L1H 1B9, Canada
Cahaba Dermatology & Skin Health Center

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 35244, United States
Apex Clinical Trials - Suncoast Skin Solutions

Apex Clinical Trials - Suncoast Skin Solutions

Lutz, Florida, 33558, United States
U.S. Dermatology Partners Rockville

U.S. Dermatology Partners Rockville

Rockville, Maryland, 20850, United States
Velocity Clinical Research at The Dermatology Clinic

Velocity Clinical Research at The Dermatology Clinic

Baton Rouge, Louisiana, 70808, United States
The Centre for Dermatology

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada
Research Toronto

Research Toronto

Toronto, Ontario, M4W 2N4, Canada
Schweiger Dermatology Group

Schweiger Dermatology Group

Verona, New Jersey, 07044, United States
UPMC Department of Dermatology

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States
MUSC Health Dermatology

MUSC Health Dermatology

Charleston, South Carolina, 29425, United States
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