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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

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2019

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Agitation; Alzheimer's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Avanir Pharmaceuticals
  • 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 has announced that it 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.The resulting decision is to continue this ongoing phase 3 trial.
    • 18 Oct 2018 Planned End Date changed from 1 Mar 2020 to 1 Jun 2021.
    • 18 Oct 2018 Planned primary completion date changed from 1 Mar 2020 to 1 Jun 2021.
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