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Trial · Interventional

TerminatedPhase 2/3Registry data

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

NCTNCT05978063 (opens ClinicalTrials.gov in a new tab)Other idCR845-310601
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2/3
Enrollment
214 participants (actual)
Sponsor
Cara Therapeutics, Inc. · Industry
Design
Randomized · Double masking
Countries
5 countries

United States, Canada, Germany, Poland, Spain

Start
1 Aug 2023
Primary completion
22 Apr 2024
Completion
7 May 2024
First posted
7 Aug 2023
Last update posted
21 Jun 2024
Conditions
Pruritus · Notalgia Paresthetica

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 2/3

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

    NCT05978063

    1 Aug 2023 to 7 May 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • difelikefalin 2.0 mg tabletsDrug
  • difelikefalin 1.0 mg tabletsDrug
  • difelikefalin 0.25 mg tabletsDrug
  • Placebo tabletsDrug

Arms4

  • Active comparator

    Difelikefalin 2.0 mg tablets

    Oral difelikefalin 2.0 mg tablet administered twice daily

  • Active comparator

    Difelikefalin 1.0 mg tablets

    Oral difelikefalin 1.0 mg tablet administered twice daily

  • Active comparator

    Difelikefalin 0.25 mg tablets

    Oral difelikefalin 0.25 mg tablet administered twice daily

  • Placebo comparator

    Placebo tablets

    Oral placebo tablet administered twice daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Proportion of Subjects with H-IGA of Clear or Almost Clear at Week 8 in Part B

    Time frame · Week 8

  6. Proportion of ≥4-point Improvement in Daily I-NRS at Day 2 in Part B

    Time frame · Day 2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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