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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Dexmedetomidine (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms TRANQUILITY III
  • Sponsors BioXcel Therapeutics

    • Most Recent Events

    • 28 Nov 2023 According to Clinicaltrial.gov, status changed from active, no longer recruiting to discontinued for business reasons; not due to safety or efficacy concerns
    • 14 Nov 2023 According to a BioXcel Therapeutics media release, the long term safety requirement for submission will be discussed with the FDA based on the observed frequency of agitation and the trial is no longer required for potential sNDA submission. Company plans to explore potential separate clinical development program for chronic agitation.
    • 04 Oct 2023 According to a BioXcel Therapeutics media release, type B/ break through meeting scheduled on October 11 in which the company plans to review its TRANQUILITY clinical trial program with the FDA and to discuss the data package required to support submission of an sNDA for the approval of BXC501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer's disease in assisted living facilities and at-home settings.

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