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A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

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Trial Profile

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2020

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Fibromyalgia; Pain
  • Focus Registrational; Therapeutic Use
  • Acronyms AFFIRM
  • Sponsors Tonix Pharmaceuticals Inc

    • Most Recent Events

    • 23 Sep 2016 Status changed from active, no longer recruiting to completed.
    • 06 Sep 2016 Top-line results published in a Tonix Pharmaceuticals Holding Corp media release.
    • 06 Sep 2016 Primary endpoint (Average perceived pain) has not been met, according to a Tonix Pharmaceuticals Holding Corp media release.

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