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A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder

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A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs Lurasidone (Primary)
  • Indications Autistic disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals

    • Most Recent Events

    • 15 Sep 2020 Results (n=537) of post-hoc pooled analysis assessing safety and efficacy of Lurasidone from six double blind, placebo-controlled, 6 weeks clinical studies in adolescents and young adults with schizophrenia presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
    • 18 Nov 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 16 Oct 2014 Status changed from recruiting to active, no longer recruiting according to ClinicalTrials.gov record.

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