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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: 15 Feb 2023

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms TRIAD-1
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 18 Jan 2023 According to ClinicalTrials.gov record, protocol has been amended as treatment arm changed from 3 to 8, study design is now Sequential parallel comparison.
    • 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-786-302 trial.
    • 02 May 2019 According to a Concert Pharmaceuticals media release, Avanir intends to publish the results in a peer-reviewed journal.
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