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

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan 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: 23 May 2024

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Sponsors Avanir Pharmaceuticals; Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 23 May 2024 According to Otsuka Pharmaceutical media release, after a detailed analysis of results from the completed trial, Otsuka and OPDC have decided to terminate the development of this drug candidate.
    • 03 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 12 Feb 2024 Primary endpoint (Change from Baseline to Week 12 in the composite Cohen-Mansfield) has not been met.

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