Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia.

Trial Profile

Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia.

Completed
Phase of Trial: Phase II

Latest Information Update: 24 May 2017

At a glance

  • Drugs Cariprazine (Primary) ; Risperidone
  • Indications Schizophrenia
  • Focus Therapeutic Use
  • Sponsors Forest Laboratories
  • Most Recent Events

    • 20 Sep 2016 Post hoc pooled analysis results of this (NCT00694707) and other trials (NCT01058096, NCT00488618, NCT00404573, NCT01104766, NCT01058668, NCT01104779) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
    • 20 Sep 2016 Post hoc pooled analysis results of this (NCT00694707) and other trial (NCT01104766) presented at the 29th Annual Congress of the European College of Neuropsychopharmacology
    • 02 Aug 2016 According to Recordati media release, following the FDA approval in September 2015, the product was launched in the USA in March 2016 under the trademark of VRAYLAR for the treatment of both bipolar mania and schizophrenia. The European Medicines Agency (EMA) started the evaluation of Richter's marketing authorisation application for cariprazine for the treatment of schizophrenia in March 2016.
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