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A Phase 3 Study of Tolperisone for the Treatment of Back Pain due to Muscle Spasms

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Trial Profile

A Phase 3 Study of Tolperisone for the Treatment of Back Pain due to Muscle Spasms

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2020

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At a glance

  • Drugs Tolperisone (Primary)
  • Indications Back pain; Spasm
  • Focus Registrational; Therapeutic Use
  • Acronyms RESUME-1
  • Sponsors Neurana Pharmaceuticals

    • Most Recent Events

    • 23 Nov 2020 According to a Neurana Pharmaceuticals media release, this study will begin enrollment imminently and anticipate topline data in the second half of 2021.
    • 02 Sep 2020 According to a Neurana Pharmaceuticals media release, this study will be presented at the PAINWeek 2020 National Conference. First subject expected to be enrolled in Fall 2020.This study is planned to enroll patients at about 60 clinical sites in the United States.
    • 23 Sep 2019 According to a Neurana Pharmaceuticals media release, given the positive results of the STAR study (NCT03802565), the company plans to conduct an end-of-Phase 2 meeting with the FDA in the first quarter of 2020 and initiate this Phase 3 clinical of tolperisone later in 2020.
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