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

June 20, 2024 updated by: Cara Therapeutics, Inc.

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, a 2-week Treatment Discontinuation Period, and a Safety Follow-up Visit (14 days after the last dose of study treatment).

Part B of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A. Part B of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, up to a 52-week OLE Period, and a Safety Follow-up Visit.

Subjects who participated in Part A of the study may not participate in Part B.

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

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 2
  • Phase 3

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
      • Montréal, Canada
        • Cara Therapeutics Study Site
      • Oshawa, Canada
        • Cara Therapeutics Study Site
      • Québec, Canada
        • Cara Therapeutics Study Site
    • Ontario
      • Oakville, Ontario, Canada
        • Cara Therapeutics Study Site
      • Peterborough, Ontario, Canada
        • Cara Therapeutics Study Site
      • Richmond Hill, Ontario, Canada
        • Cara Therapeutics Study Site
      • Toronto, Ontario, Canada
        • Cara Therapeutics Study Site
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Cara Therapeutics Study Site
  • Germany
      • Bad Bentheim, Germany
        • Cara Therapeutics Study Site
      • Berlin, Germany
        • Cara Therapeutics Study Site
      • Heidelberg, Germany
        • Cara Therapeutics Study Site
      • Langenau, Germany
        • Cara Therapeutics Study Site 2
      • Langenau, Germany
        • Cara Therapeutics Study Site
  • Poland
      • Katowice, Poland
        • Cara Therapeutics Study Site
      • Katowice, Poland
        • Cara Therapeutics Study Site 2
      • Sosnowiec, Poland
        • Cara Therapeutics Study Site
      • Szczecin, Poland
        • Cara Therapeutics Study Site
      • Wrocław, Poland
        • Cara Therapeutics Study Site
  • Spain
      • Bilbao, Spain
        • Cara Therapeutics Study Site
      • Madrid, Spain
        • Cara Therapeutics Study Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cara Therapeutics Study Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Cara Therapeutics Study Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Cara Therapeutics Study Site
      • Hot Springs, Arkansas, United States, 71913
        • Cara Therapeutics Study Site
    • California
      • Encino, California, United States, 91436
        • Cara Therapeutics Study Site
      • Fountain Valley, California, United States, 92708
        • Cara Therapeutics Study Site
      • Los Angeles, California, United States, 90045
        • Cara Therapeutics Study Site
      • Northridge, California, United States, 91324
        • Cara Therapeutics Study Site
      • Valencia, California, United States, 91355
        • Cara Therapeutics Study Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Cara Therapeutics Study Site
      • Hollywood, Florida, United States, 33021
        • Cara Therapeutics Study Site
      • Lutz, Florida, United States, 33558
        • Cara Therapeutics Study Site
      • Margate, Florida, United States, 33063
        • Cara Therapeutics Study Site
      • Tampa, Florida, United States, 33607
        • Cara Therapeutics Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Cara Therapeutics Study Site
      • Plainfield, Indiana, United States, 46168
        • Cara Therapeutics Study Site
      • West Lafayette, Indiana, United States, 47906
        • Cara Therapeutics Study Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Cara Therapeutics Study Site
      • Baton Rouge, Louisiana, United States, 70808
        • Cara Therapeutics Study Site
      • Metairie, Louisiana, United States, 70006
        • Cara Therapeutics Study Site
      • New Orleans, Louisiana, United States, 70115
        • Cara Therapeutics Study Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Cara Therapeutics Study Site
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Cara Therapeutics Study Site
    • Nevada
      • Reno, Nevada, United States, 89509
        • Cara Therapeutics Study Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Cara Therapeutics Study Site
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Cara Therapeutics Study Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Cara Therapeutics Study Site
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Cara Therapeutics Study Site
      • Mason, Ohio, United States, 45040
        • Cara Therapeutics Study Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Cara Therapeutics Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Cara Therapeutics Study Site
    • Tennessee
      • Thompson's Station, Tennessee, United States, 37179
        • Cara Therapeutics Study Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Cara Therapeutics Study Site
      • Houston, Texas, United States, 77056
        • Cara Therapeutics Study Site
      • Pflugerville, Texas, United States, 78660
        • Cara Therapeutics Study Site
      • San Antonio, Texas, United States, 78213
        • Cara Therapeutics Study Site
      • Webster, Texas, United States, 77598
        • 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

  • 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
Active Comparator: Difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg tablet administered twice daily
Drug: difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg administered twice daily
Other Names:
  • CR845
Active Comparator: Difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg tablet administered twice daily
Drug: difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg administered twice daily
Other Names:
  • CR845
Active Comparator: Difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg tablet administered twice daily
Drug: difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg administered twice daily
Other Names:
  • CR845
Placebo Comparator: Placebo tablets
Oral placebo tablet administered twice daily
Drug: Placebo tablets
Oral Placebo administered twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4 in Part B
Time Frame: Baseline, Week 4
Baseline, Week 4
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2 in Part B
Time Frame: Baseline, Week 2
Baseline, Week 2
Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1 in Part B
Time Frame: Baseline, Week 1
Baseline, Week 1
Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B
Time Frame: Baseline, Week 8
Baseline, Week 8
Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
Time Frame: Week 8
Week 8
Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B
Time Frame: Day 2
Day 2

Collaborators and Investigators

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

Sponsor

Cara Therapeutics, Inc.

Investigators

  • Study Director: Cara Therapeutics, 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)

August 1, 2023

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

May 7, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR845-310601

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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