Phase 2 Trial of Difelikefalin in Notalgia Paresthetica.

Kim BS, Bissonnette R, Nograles K, Munera C, Shah N, Jebara A, Cirulli J, Goncalves J, Lebwohl M

The New England journal of medicine1 Feb 2023Cited by 25 (Europe PMC)

PMID36780675DOI10.1056/nejmoa2210699PepBankPUB-36780675

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In notalgia paresthetica, WI-NRS changed by -4.0 with difelikefalin versus -2.4 with placebo (difference -1.6, 95% CI -2.6 to -0.6, P = 0.001).
In plain wordsIn patients with notalgia paresthetica, difelikefalin reduced itch scores more than placebo.
Peptide
Difelikefalin
Outcome
DecreaseWI-NRS change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Measurements
Change from baseline in weekly mean WI-NRS at week 8
−4 points
difelikefalin group
Change from baseline in weekly mean WI-NRS at week 8
−2.4 points
placebo group
Difference in change in weekly mean WI-NRS at week 8
−1.6 points
difelikefalin versus placebo
95% CI of difference in change in weekly mean WI-NRS
−2.6 to −0.6 points
difelikefalin versus placebo
Source sentences
Summary
The change from baseline in the weekly mean WI-NRS score at week 8 was -4.0 points in the difelikefalin group and -2.4 points in the placebo group (difference in change, -1.6 points; 95% confidence interval, -2.6 to -0.6; P = 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067501
02HumanRandomized controlled trialEfficacy outcome
In notalgia paresthetica, difelikefalin secondary outcome results generally did not support the primary analysis.
In plain wordsDifelikefalin secondary results generally did not support the primary benefit versus placebo.
Peptide
Difelikefalin
Outcome
Direction not reportedSecondary itch-related quality-of-life and sleep outcomes
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Source sentences
Summary
The results for the secondary outcomes generally did not support those of the primary analysis.
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary clinical outcomes were itch-related quality-of-life and itch-related sleep measures.
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067502
03HumanRandomized controlled trialSafety outcome
In notalgia paresthetica, headache occurred more frequently with difelikefalin than placebo.
In plain wordsPatients receiving difelikefalin had more headaches than those receiving placebo.
Peptide
Difelikefalin
Outcome
IncreaseHeadache
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Source sentences
Summary
Headache, dizziness, constipation, and increased urine output occurred more frequently in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067503
04HumanRandomized controlled trialSafety outcome
In notalgia paresthetica, dizziness occurred more frequently with difelikefalin than placebo.
In plain wordsPatients receiving difelikefalin had more dizziness than those receiving placebo.
Peptide
Difelikefalin
Outcome
IncreaseDizziness
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Source sentences
Summary
Headache, dizziness, constipation, and increased urine output occurred more frequently in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067504
05HumanRandomized controlled trialSafety outcome
In notalgia paresthetica, constipation occurred more frequently with difelikefalin than placebo.
In plain wordsPatients receiving difelikefalin had more constipation than those receiving placebo.
Peptide
Difelikefalin
Outcome
IncreaseConstipation
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Source sentences
Summary
Headache, dizziness, constipation, and increased urine output occurred more frequently in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067505
06HumanRandomized controlled trialSafety outcome
In notalgia paresthetica, increased urine output occurred more frequently with difelikefalin than placebo.
In plain wordsPatients receiving difelikefalin more often had increased urine output than those receiving placebo.
Peptide
Difelikefalin
Outcome
IncreaseIncreased urine output
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Kidney and urinary
Studied dose
2 mg twice daily · oral · 8 weeksAs given in this study (human).
Source sentences
Summary
Headache, dizziness, constipation, and increased urine output occurred more frequently in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase 2, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, patients with moderate-to-severe pruritus caused by notalgia paresthetica to receive 2 mg of oral difelikefalin or placebo twice daily for 8 weeks.
Report a problemFND-3678067506

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT04706975

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

Cara Therapeutics, Inc.n = 12611 Jan 2021 to 30 Jun 2022

Pruritus · Notalgia Paresthetica

Trial page ClinicalTrials.govUpdated 22 May 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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MeSH terms

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