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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

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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: 10 Apr 2024

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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

    • 02 Apr 2024 According to a Rovi Media release, based upon positive results from this trial the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan (Risperidone ISM) for the treatment of schizophrenia in adults.
    • 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

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