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Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM in Patients With Acute Exacerbation of Schizophrenia

Trial Profile

Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM in Patients With Acute Exacerbation of Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Feb 2023

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At a glance

  • Drugs Risperidone (Primary) ; Risperidone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms PRISMA-3
  • Sponsors Rovi
  • Most Recent Events

    • 16 Feb 2023 According to a Rovi Media release, the company filed the final responses to the Complete Response Letter received from the United States Food and Drug Administration (FDA) in the third quarter of 2022. User fee goal date is 27 July 2023.
    • 18 Oct 2022 Results assessing extrapyramidal symptoms of Risperidone ISM (Risp-ISM) in patients with schizophrenia during the double blind phase of the PRISMA-3 study presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
    • 18 Oct 2022 Results from NCT03160521 and NCT03870880, evaluating the cardiovascular safety of Risperidone, presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
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