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

NCT ID: NCT05978063

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-05-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pruritus Notalgia Paresthetica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A includes 4 arms and Part B includes 2 arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Difelikefalin 2.0 mg tablets

Oral difelikefalin 2.0 mg tablet administered twice daily

Group Type ACTIVE_COMPARATOR

difelikefalin 2.0 mg tablets

Intervention Type DRUG

Oral difelikefalin 2.0 mg administered twice daily

Difelikefalin 1.0 mg tablets

Oral difelikefalin 1.0 mg tablet administered twice daily

Group Type ACTIVE_COMPARATOR

difelikefalin 1.0 mg tablets

Intervention Type DRUG

Oral difelikefalin 1.0 mg administered twice daily

Difelikefalin 0.25 mg tablets

Oral difelikefalin 0.25 mg tablet administered twice daily

Group Type ACTIVE_COMPARATOR

difelikefalin 0.25 mg tablets

Intervention Type DRUG

Oral difelikefalin 0.25 mg administered twice daily

Placebo tablets

Oral placebo tablet administered twice daily

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

Oral Placebo administered twice daily

Interventions

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difelikefalin 2.0 mg tablets

Oral difelikefalin 2.0 mg administered twice daily

Intervention Type DRUG

difelikefalin 1.0 mg tablets

Oral difelikefalin 1.0 mg administered twice daily

Intervention Type DRUG

difelikefalin 0.25 mg tablets

Oral difelikefalin 0.25 mg administered twice daily

Intervention Type DRUG

Placebo tablets

Oral Placebo administered twice daily

Intervention Type DRUG

Other Intervention Names

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CR845 CR845 CR845

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cara Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cara Therapeutics

Role: STUDY_DIRECTOR

Cara Therapeutics

Locations

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Cara Therapeutics Study Site

Birmingham, Alabama, United States

Site Status

Cara Therapeutics Study Site

Phoenix, Arizona, United States

Site Status

Cara Therapeutics Study Site

Fayetteville, Arkansas, United States

Site Status

Cara Therapeutics Study Site

Hot Springs, Arkansas, United States

Site Status

Cara Therapeutics Study Site

Encino, California, United States

Site Status

Cara Therapeutics Study Site

Fountain Valley, California, United States

Site Status

Cara Therapeutics Study Site

Los Angeles, California, United States

Site Status

Cara Therapeutics Study Site

Northridge, California, United States

Site Status

Cara Therapeutics Study Site

Valencia, California, United States

Site Status

Cara Therapeutics Study Site

Coral Gables, Florida, United States

Site Status

Cara Therapeutics Study Site

Hollywood, Florida, United States

Site Status

Cara Therapeutics Study Site

Lutz, Florida, United States

Site Status

Cara Therapeutics Study Site

Margate, Florida, United States

Site Status

Cara Therapeutics Study Site

Tampa, Florida, United States

Site Status

Cara Therapeutics Study Site

Indianapolis, Indiana, United States

Site Status

Cara Therapeutics Study Site

Plainfield, Indiana, United States

Site Status

Cara Therapeutics Study Site

West Lafayette, Indiana, United States

Site Status

Cara Therapeutics Study Site

Baton Rouge, Louisiana, United States

Site Status

Cara Therapeutics Study Site

Baton Rouge, Louisiana, United States

Site Status

Cara Therapeutics Study Site

Metairie, Louisiana, United States

Site Status

Cara Therapeutics Study Site

New Orleans, Louisiana, United States

Site Status

Cara Therapeutics Study Site

Rockville, Maryland, United States

Site Status

Cara Therapeutics Study Site

Fort Gratiot, Michigan, United States

Site Status

Cara Therapeutics Study Site

Reno, Nevada, United States

Site Status

Cara Therapeutics Study Site

Portsmouth, New Hampshire, United States

Site Status

Cara Therapeutics Study Site

Verona, New Jersey, United States

Site Status

Cara Therapeutics Study Site

Fargo, North Dakota, United States

Site Status

Cara Therapeutics Study Site

Boardman, Ohio, United States

Site Status

Cara Therapeutics Study Site

Mason, Ohio, United States

Site Status

Cara Therapeutics Study Site

Pittsburgh, Pennsylvania, United States

Site Status

Cara Therapeutics Study Site

Charleston, South Carolina, United States

Site Status

Cara Therapeutics Study Site

Thompson's Station, Tennessee, United States

Site Status

Cara Therapeutics Study Site

Dallas, Texas, United States

Site Status

Cara Therapeutics Study Site

Houston, Texas, United States

Site Status

Cara Therapeutics Study Site

Pflugerville, Texas, United States

Site Status

Cara Therapeutics Study Site

San Antonio, Texas, United States

Site Status

Cara Therapeutics Study Site

Webster, Texas, United States

Site Status

Cara Therapeutics Study Site

Spokane, Washington, United States

Site Status

Cara Therapeutics Study Site

Oakville, Ontario, Canada

Site Status

Cara Therapeutics Study Site

Peterborough, Ontario, Canada

Site Status

Cara Therapeutics Study Site

Richmond Hill, Ontario, Canada

Site Status

Cara Therapeutics Study Site

Toronto, Ontario, Canada

Site Status

Cara Therapeutics Study Site

Sherbrooke, Quebec, Canada

Site Status

Cara Therapeutics Study Site

Montreal, , Canada

Site Status

Cara Therapeutics Study Site

Oshawa, , Canada

Site Status

Cara Therapeutics Study Site

Québec, , Canada

Site Status

Cara Therapeutics Study Site

Bad Bentheim, , Germany

Site Status

Cara Therapeutics Study Site

Berlin, , Germany

Site Status

Cara Therapeutics Study Site

Heidelberg, , Germany

Site Status

Cara Therapeutics Study Site 2

Langenau, , Germany

Site Status

Cara Therapeutics Study Site

Langenau, , Germany

Site Status

Cara Therapeutics Study Site 2

Katowice, , Poland

Site Status

Cara Therapeutics Study Site

Katowice, , Poland

Site Status

Cara Therapeutics Study Site

Sosnowiec, , Poland

Site Status

Cara Therapeutics Study Site

Szczecin, , Poland

Site Status

Cara Therapeutics Study Site

Wroclaw, , Poland

Site Status

Cara Therapeutics Study Site

Bilbao, , Spain

Site Status

Cara Therapeutics Study Site

Madrid, , Spain

Site Status

Countries

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United States Canada Germany Poland Spain

Other Identifiers

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CR845-310601

Identifier Type: -

Identifier Source: org_study_id

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