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A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia

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Trial Profile

A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Ulotaront (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals

    • Most Recent Events

    • 09 Nov 2021 Results of pooled analysis evaluating novelty of a safety profile of a drug in a new class (in clinical trials), against that of those already on the market (using pharmacovigilance data) published in the Clinical Drug Investigation
    • 05 Oct 2021 Results of an analysis assessing effects of SEP-363856 on negative symptoms in initial double-blind study and 6-month open-label extension study presented at the 34th Annual Congress of the European College of Neuropsychopharmacology
    • 05 Oct 2021 Results of pooled analysis assessing the adverse event signals of this first agent in a novel drug class that differentiate it from the available class of atypical antipsychotics, presented at the 34th Annual Congress of the European College of Neuropsychopharmacology.
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