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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 24 Jun 2024

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At a glance

  • Drugs Difelikefalin (Primary)
  • Indications Paraesthesia
  • Focus Registrational; Therapeutic Use
  • Acronyms KOURAGE 1
  • Sponsors Cara Therapeutics

Most Recent Events

  • 20 Jun 2024 Status changed from recruiting to discontinued as In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profilesimilar to prior trials.
  • 12 Jun 2024 Results of this study presented in Cara Therapeutics the Media Release.
  • 13 May 2024 According to Cara Therapeutics media release, company expects to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024.

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