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A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

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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 in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Feb 2025

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Post-traumatic stress disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms RECOVERY
  • Sponsors Tonix Pharmaceuticals Holding Corp

    • Most Recent Events

    • 21 Dec 2020 Topline results presented in a Tonix Pharmaceuticals media release.
    • 05 Feb 2020 According to a Tonix Pharmaceuticals media release, primary endpoint (The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit.) has not been met.
    • 05 Feb 2020 According to a Tonix Pharmaceuticals media release, company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data to determine the next steps in this program, with the topline results expected to be reported in the second quarter of 2020.

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