A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2017

At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIAD-1
  • Sponsors Avanir Pharmaceuticals
  • Most Recent Events

    • 17 Nov 2015 According to an Otsuka Pharmaceutical media release, this clinical trial has been granted "Fast Track" status (priority approval system) by the U.S. Food and Drug Administration.
    • 17 Nov 2015 Status changed from not yet recruiting to recruiting, as reported in an Otsuka Pharmaceutical media release.
    • 05 Aug 2015 According to a Concert Pharmaceuticals media release, company plans to initiate this study in September 2015.
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