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A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)

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Trial Profile

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2018

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At a glance

  • Drugs Dextromethorphan/quinidine (Primary)
  • Indications Emotional lability
  • Focus Registrational; Therapeutic Use
  • Acronyms STAR
  • Sponsors Avanir Pharmaceuticals

    • Most Recent Events

    • 28 Apr 2017 Results (n=253) assessing prolonged effectiveness of Dextromethorphan Hydrobromide/Quinidine Sulfate presented at the 69th Annual Meeting of the American Academy of Neurology.
    • 03 May 2014 Results of a post-hoc analysis (n=216) presented at the 66th Annual Meeting of the American Academy of Neurology.
    • 28 Apr 2014 The results of a post-hoc analysis were presented at the 66th Annual Meeting of the American Academy of Neurology (AAN) in April 2014.

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