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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

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

    • 03 Apr 2018 According to a Tonix Pharmaceuticals media release, 50 percent of the planned total number of participants have been randomized in this trial. An interim analysis of these participants will be conducted shortly after the 12-week treatment period has been completed. Topline efficacy results from the interim analysis are expected in the third quarter of this year. The company expects to file an NDA for Tonmya in 2019.
    • 09 Jan 2018 According to a Tonix Pharmaceuticals Incmedia release, topline data expected in the fourth quarter of 2018.
    • 01 Nov 2017 According to a Tonix Pharmaceuticals Holding Corp media release, An unblinded interim analysis will be conducted once the study has accumulated efficacy results from approximately 275 randomized participants.
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