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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).

Trial Profile

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Nov 2019

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Aggression; Agitation; Irritability
  • Focus Therapeutic Use
  • Sponsors Avanir Pharmaceuticals
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 03 Jan 2018 Planned End Date changed from 1 Dec 2019 to 1 Jun 2020.
    • 03 Jan 2018 Planned primary completion date changed from 1 Dec 2019 to 1 Jun 2020.
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