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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)

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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: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Oct 2023

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At a glance

  • Drugs Deudextromethorphan (Primary)
  • Indications Aggression; Agitation; Irritability
  • Focus Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 22 Aug 2023 Number of treatment arms has been changed from 2 to 6.
    • 14 Oct 2022 Status changed from active, no longer recruiting to completed.
    • 25 Aug 2022 Status changed from recruiting to active, no longer recruiting.

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