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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2021

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies

    • Most Recent Events

    • 18 Dec 2018 According to a Pomerantz LLP media release, on behalf of investors of Intra-Cellular Therapies, an independent data monitoring committee (DMC) recommended discontinuation of the trial based on the high likelihood of a futile primary endpoint outcome, in a pre-specified interim analysis of the trial. In accordance with this recommendation, the company elected to discontinue the trial
    • 18 Dec 2018 Status changed from recruiting to discontinued.
    • 01 Mar 2018 According to an Intra-Cellular Therapies media release, outcome of the interim analysis for this trial will be available in 2H 2018

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