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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: 30 Jul 2019

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At a glance

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

    • 30 Jul 2019 According to an Rovi Media release, the company will include long-term safety data on more than 100 patients exposed to at least one year of treatment with Doria in the registration dossier, as recommended in the International Conference on Harmonization (ICH) Guideline E1.
    • 30 Jul 2019 According to an Rovi Media release, the company will prioritize the submission of the Doria dossier in Europe by 1Q 2020 and consequently, filing in the USA has been rescheduled for 2020.
    • 19 Mar 2019 Results presented in a Rovi media release.
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