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Difelikefalin for Itching

Verified Trial
Phase 2 & 3
Recruiting
Research Sponsored by Cara Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has clinically confirmed diagnosis of active Notalgia Paresthetica
Subject has a history of chronic pruritus due to Notalgia Paresthetica
Timeline
Screening 2 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial tests a drug to treat itchy skin in adults with nerve-related skin conditions. It's a double-blind, placebo-controlled study to evaluate safety and effectiveness.

Who is the study for?
This trial is for adults with chronic itching due to Notalgia Paresthetica (NP), who experience moderate to severe pruritus. Participants must not be pregnant or nursing and should have a confirmed diagnosis of active NP. Those with medical conditions that could risk their safety or affect the study's results are excluded.Check my eligibility
What is being tested?
The study tests three different doses of oral difelikefalin tablets (0.25 mg, 1.0 mg, and 2.0 mg) against placebo tablets to assess their effectiveness and safety in treating itchiness from NP when taken twice daily.See study design
What are the potential side effects?
While specific side effects for difelikefalin aren't provided here, common ones may include dizziness, headache, dry mouth, nausea, constipation or diarrhea; however individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Notalgia Paresthetica.
Select...
I have long-term itching due to Notalgia Paresthetica.
Select...
I often have moderate to severe itching.
Select...
I am not pregnant or breastfeeding.
Select...
I have itching on the upper middle part of my back.

Timeline

Screening ~ 2 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 2 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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 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
+3 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Difelikefalin 0.25 mg tabletsActive Control1 Intervention
Oral difelikefalin 0.25 mg tablet administered twice daily
Group II: Difelikefalin 2.0 mg tabletsActive Control1 Intervention
Oral difelikefalin 2.0 mg tablet administered twice daily
Group III: Difelikefalin 1.0 mg tabletsActive Control1 Intervention
Oral difelikefalin 1.0 mg tablet administered twice daily
Group IV: Placebo tabletsPlacebo Group1 Intervention
Oral placebo tablet administered twice daily

Find a Location

Who is running the clinical trial?

Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
5,338 Total Patients Enrolled
Cara TherapeuticsStudy DirectorCara Therapeutics
1 Previous Clinical Trials
287 Total Patients Enrolled

Media Library

Difelikefalin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05978063 — Phase 2 & 3
Itching Research Study Groups: Placebo tablets, Difelikefalin 0.25 mg tablets, Difelikefalin 2.0 mg tablets, Difelikefalin 1.0 mg tablets
Itching Clinical Trial 2023: Difelikefalin Highlights & Side Effects. Trial Name: NCT05978063 — Phase 2 & 3
Difelikefalin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978063 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I volunteer for this scientific investigation?

"To enroll in this research program, potential participants must possess an itchy condition and be between 18 to 80 years old. The total enrolment for the study is slated at 440 patients."

Answered by AI

Does this medical trial's eligibility criteria encompass individuals over thirty years of age?

"Those wishing to be considered for this trial must fall within the age range of 18-80. There are an additional 9 trials specifically designed for minors and 232 studies reserved for elderly individuals older than 65 years old."

Answered by AI

Is there current availability for enrolment in this clinical trial?

"As per the details provided on clinicialtrials.gov, this clinical trial is still seeking applicants. The initial posting was made on August 1st 2023 and the latest update was released 2 days later."

Answered by AI

How many individuals are participating in this experiment?

"Affirmative. According to the information accessible on clinicaltrials.gov, recruitment is still open for this experiment which was first listed on August 1st 2023 and revised a few days later on the 3rd of that month. A total of 440 people need to be enrolled at one site."

Answered by AI

Who else is applying?

What site did they apply to?
Cara Therapeutics Study Site
Other
Clinical Trials Management - Southshore
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have Cancer. Get extra money. I seen it online. Like to help other people.
PatientReceived 2+ prior treatments
I’d like to get paid to treat something that annoys me.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Clinical Trials Management - Southshore: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
2023. "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05978063.
All > Fargo > Spokane
~293 spots leftby Mar 2026
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