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NCT05978063 Clinical Trial

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

Pruritus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05978063
Other study ID # CR845-310601
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date August 1, 2023
Est. completion date May 7, 2024

Study information
Verified date June 2024
Source Cara Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 214
Est. completion date May 7, 2024
Est. primary completion date April 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• difelikefalin 2.0 mg tablets
Oral difelikefalin 2.0 mg administered twice daily
• difelikefalin 1.0 mg tablets
Oral difelikefalin 1.0 mg administered twice daily
• difelikefalin 0.25 mg tablets
Oral difelikefalin 0.25 mg administered twice daily
• Placebo tablets
Oral Placebo administered twice daily

Locations
Country Name City State
Canada Cara Therapeutics Study Site Montréal
Canada Cara Therapeutics Study Site Oakville Ontario
Canada Cara Therapeutics Study Site Oshawa
Canada Cara Therapeutics Study Site Peterborough Ontario
Canada Cara Therapeutics Study Site Québec
Canada Cara Therapeutics Study Site Richmond Hill Ontario
Canada Cara Therapeutics Study Site Sherbrooke Quebec
Canada Cara Therapeutics Study Site Toronto Ontario
Germany Cara Therapeutics Study Site 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
Poland Cara Therapeutics Study Site Katowice
Poland Cara Therapeutics Study Site 2 Katowice
Poland Cara Therapeutics Study Site Sosnowiec
Poland Cara Therapeutics Study Site Szczecin
Poland Cara Therapeutics Study Site Wroclaw
Spain Cara Therapeutics Study Site Bilbao
Spain Cara Therapeutics Study Site Madrid
United States Cara Therapeutics Study Site Baton Rouge Louisiana
United States Cara Therapeutics Study Site Baton Rouge Louisiana
United States Cara Therapeutics Study Site Birmingham Alabama
United States Cara Therapeutics Study Site Boardman Ohio
United States Cara Therapeutics Study Site Charleston South Carolina
United States Cara Therapeutics Study Site Coral Gables Florida
United States Cara Therapeutics Study Site Dallas Texas
United States Cara Therapeutics Study Site Encino California
United States Cara Therapeutics Study Site Fargo North Dakota
United States Cara Therapeutics Study Site Fayetteville Arkansas
United States Cara Therapeutics Study Site Fort Gratiot Michigan
United States Cara Therapeutics Study Site Fountain Valley California
United States Cara Therapeutics Study Site Hollywood Florida
United States Cara Therapeutics Study Site Hot Springs Arkansas
United States Cara Therapeutics Study Site Houston Texas
United States Cara Therapeutics Study Site Indianapolis Indiana
United States Cara Therapeutics Study Site Los Angeles California
United States Cara Therapeutics Study Site Lutz Florida
United States Cara Therapeutics Study Site Margate Florida
United States Cara Therapeutics Study Site Mason Ohio
United States Cara Therapeutics Study Site Metairie Louisiana
United States Cara Therapeutics Study Site New Orleans Louisiana
United States Cara Therapeutics Study Site Northridge California
United States Cara Therapeutics Study Site Pflugerville Texas
United States Cara Therapeutics Study Site Phoenix Arizona
United States Cara Therapeutics Study Site Pittsburgh Pennsylvania
United States Cara Therapeutics Study Site Plainfield Indiana
United States Cara Therapeutics Study Site Portsmouth New Hampshire
United States Cara Therapeutics Study Site Reno Nevada
United States Cara Therapeutics Study Site Rockville Maryland
United States Cara Therapeutics Study Site San Antonio Texas
United States Cara Therapeutics Study Site Spokane Washington
United States Cara Therapeutics Study Site Tampa Florida
United States Cara Therapeutics Study Site Thompson's Station Tennessee
United States Cara Therapeutics Study Site Valencia California
United States Cara Therapeutics Study Site Verona New Jersey
United States Cara Therapeutics Study Site Webster Texas
United States Cara Therapeutics Study Site West Lafayette Indiana

Sponsors (1)
Lead Sponsor Collaborator
Cara Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Spain, 

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