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A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement

Trial Profile

A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Nov 2019

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At a glance

  • Drugs Brivoligide (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Adynxx
  • Most Recent Events

    • 14 Nov 2019 According to an Adynxx media release, the company plans to commence this trial as early as the first quarter of 2020. Topline data from this study is expected in first half of 2021.
    • 22 Apr 2019 According to an Adynxx media release, the company plans to initiate this study in 2019.Topline data from this study is expected in 2020.
    • 13 Dec 2018 According to an Adynxx media release, Adynxx has received Notice of Award from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), for an award to support the clinical development of brivoligide injection (brivoligide) for postoperative pain.The grant award received by Adynxx will provide Adynxx with $5.7 million over the two-year UG3 phase to complete this phase 2 study in patients undergoing mastectomy.
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