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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIAD-2
  • Sponsors Avanir Pharmaceuticals; Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 12 Nov 2019 According to an Avanir Pharmaceuticals media release, based on insights derived from detailed analysis of data from the first and second phase 3 AVP-786 clinical trials (15-AVP-786-301 and 15-AVP-786-302), the company will continue the clinical development program of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with Alzheimer's dementia.
    • 12 Nov 2019 According to an Otsuka Pharmaceutical media release, the company and its U.S.-based, indirect subsidiary Avanir Pharmaceuticals, Inc. have decided to to continue the clinical development program of AVP-786 for the treatment of agitation in patients with Alzheimer's dementia, based on the data from this and 15-AVP-786-301 trial.
    • 27 Sep 2019 Primary endpoint has not been met. (Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score), according to an Avanir Pharmaceuticals media release.
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