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Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment

Trial Profile

Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 26 Jun 2024

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At a glance

  • Drugs Dexmedetomidine (Primary)
  • Indications Agitation
  • Focus Therapeutic Use
  • Sponsors BioXcel Therapeutics

Most Recent Events

  • 25 Jun 2024 According to the BioXcel Therapeutics Media Release, This study showed the 180 mcg dose worked without losing effectiveness or causing withdrawal, reducing agitation over a week without serious side effects, These results support the ongoing Phase 3 SERENITY and TRANQUILITY programs.
  • 25 Jun 2024 According to the BioXcel Therapeutics Media Release, the company looks forward to sharing these IGALMI PMR data with FDA.
  • 25 Jun 2024 Positive topline results presented in the BioXcel Therapeutics Media Release

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