Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

May 17, 2023 updated by: Cara Therapeutics, Inc.

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 days after the last dose of study drug.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 2.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension period upon completion of the Week 8 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Markham, Canada
        • Cara Therapeutics Study Site
      • Montréal, Canada
        • Cara Therapeutics Study Site
      • Peterborough, Canada
        • Cara Therapeutics Study Site
      • Surrey, Canada
        • Cara Therapeutics Study Site
      • Winnipeg, Canada
        • Cara Therapeutics Study Site
    • British Columbia
      • Surrey, British Columbia, Canada
        • Cara Therapeutics Study Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Cara Therapeutics Study Site
    • Ontario
      • Markham, Ontario, Canada
        • Cara Therapeutics Study Site
      • Peterborough, Ontario, Canada
        • Cara Therapeutics Study Site
    • Quebec
      • Montréal, Quebec, Canada
        • Cara Therapeutics Study Site
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Cara Therapeutics Study Site
      • Hot Springs, Arkansas, United States, 71913
        • Cara Therapeutics Study Site
      • Rogers, Arkansas, United States, 72758
        • Cara Therapeutics Study Site
    • California
      • Fountain Valley, California, United States, 92708
        • Cara Therapeutics Study Site
      • Los Angeles, California, United States, 90033
        • Cara Therapeutics Study Site
      • San Diego, California, United States, 92122
        • Cara Therapeutics Study Site
      • Santa Monica, California, United States, 90404
        • Cara Therapeutics Study Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Cara Therapeutics Study Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Cara Therapeutics Study Site
      • Margate, Florida, United States, 33063
        • Cara Therapeutics Study Site
      • Miami, Florida, United States, 33144
        • Cara Therapeutics Study Site
      • North Miami Beach, Florida, United States, 33162
        • Cara Therapeutics Study Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Cara Therapeutics Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Cara Therapeutics Study Site
      • Plainfield, Indiana, United States, 46168
        • Cara Therapeutics Study Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Cara Therapeutics Study Site
    • New York
      • New York, New York, United States, 10029
        • Cara Therapeutics Study Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Cara Therapeutics Study Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Cara Therapeutics Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Cara Therapeutics Study Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Cara Therapeutics Study Site
      • Pflugerville, Texas, United States, 78660
        • Cara Therapeutics Study Site
      • San Antonio, Texas, United States, 78213
        • Cara Therapeutics Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Cara Therapeutics Study Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Cara Therapeutics Study Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Cara Therapeutics Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

  • Subject has clinically confirmed diagnosis of active Notalgia Paresthetica;
  • Subject has a history of chronic pruritus due to Notalgia Paresthetica;
  • Subject has moderate to severe pruritus;
  • Female subject is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

  • Subject has pruritus attributed to a cause other than Notalgia Paresthetica;
  • Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral placebo tablet administered twice daily
Drug: Placebo
Oral Placebo administered twice daily
Active Comparator: Difelikefalin 2.0 mg
Oral difelikefalin 2.0 mg tablet administered twice daily
Drug: difelikefalin 2.0 mg
Oral difelikefalin 2.0 mg administered twice daily
Other Names:
  • CR845

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
Time Frame: Baseline, Week 8
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cara Therapeutics, Inc.

Investigators

  • Study Director: Nilam Shah, Cara Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Actual)

May 18, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR845-210601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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