A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Trial Profile

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Bupropion/dextromethorphan (Primary)
  • Indications Agitation
  • Focus Therapeutic Use
  • Acronyms ADvance; ADVANCE-1
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 24 Jul 2017 Planned End Date changed from 1 Jul 2020 to 1 Sep 2019.
    • 24 Jul 2017 Planned primary completion date changed from 1 Jun 2020 to 1 Aug 2019.
    • 17 Jul 2017 According to an Axsome Therapeutics media release, this trial incorporates a planned interim analysis by an independent data monitoring committee to assess the assumptions used to determine the sample size of the trial.
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