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

Primary Purpose

Pruritus, Notalgia Paresthetica

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
difelikefalin 2.0 mg tablets
difelikefalin 1.0 mg tablets
difelikefalin 0.25 mg tablets
Placebo tablets
Sponsored by
Cara Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting
  • Cara Therapeutics Study SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Difelikefalin 2.0 mg tablets

Difelikefalin 1.0 mg tablets

Difelikefalin 0.25 mg tablets

Placebo tablets

Arm Description

Oral difelikefalin 2.0 mg tablet administered twice daily

Oral difelikefalin 1.0 mg tablet administered twice daily

Oral difelikefalin 0.25 mg tablet administered twice daily

Oral placebo tablet administered twice daily

Outcomes

Primary Outcome Measures

Proportion of subjects achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score

Secondary Outcome Measures

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
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
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
Change from Baseline in the Numeric Rating Scale of Burning Sensation and Skin Tingling at Week 8 in Part B
Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B

Full Information

First Posted
July 25, 2023
Last Updated
October 5, 2023
Sponsor
Cara Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05978063
Brief Title
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Notalgia Paresthetica
Keywords
Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Part A includes 4 arms and Part B includes 2 arms.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Difelikefalin 2.0 mg tablets
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 2.0 mg tablet administered twice daily
Arm Title
Difelikefalin 1.0 mg tablets
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 1.0 mg tablet administered twice daily
Arm Title
Difelikefalin 0.25 mg tablets
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 0.25 mg tablet administered twice daily
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
Oral placebo tablet administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 2.0 mg tablets
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 2.0 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 1.0 mg tablets
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 1.0 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 0.25 mg tablets
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 0.25 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
Oral Placebo administered twice daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B
Time Frame
Week 8
Title
Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cara Therapeutics
Phone
203-406-3700
Email
clinicaltrials.gov@caratherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cara Therapeutics
Organizational Affiliation
Cara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cara Therapeutics Study Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Thompson's Station
State/Province
Tennessee
ZIP/Postal Code
37179
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Oshawa
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cara Therapeutics Study Site
City
Québec
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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